MODO DUO Electric Pump (B11621, B11673)
Tomy International, Inc. · Obstetrics/Gynecology
Open FDA's page for this record- Third party flag
- N
- City
- Dyersville
- Advisory committee description
- Obstetrics/Gynecology
- Address 1
- 2021 9th St. SE
- Statement or summary
- Summary
- Product code
- HGX
- Zip code
- 52040
- Applicant
- Tomy International, Inc.
- Decision date
- 2026-10-16
- Decision code
- SESE
- Country code
- US
- Device name
- MODO DUO Electric Pump (B11621, B11673)
- Advisory committee
- OB
- Contact
- Kenneth Li
- K number
- K261782
- State
- IA
- Date received
- 2026-05-29
- Review advisory committee
- OB
- Postal code
- 52040
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Pump, Breast, Powered
- Medical specialty description
- Obstetrics/Gynecology
- Regulation number
- 884.5160
- Device class
- 2
- Registration number
- 3006852457, 3009974348, 3010880718, 3002807523, 3020994856, 3027115730, 3014166044, 3030479957, 3003927385, 3009243271, 3003899230, 3012188053, 3020034975, 3009700166, 3021376102, 3038613158, 3012062596, 3031841858, 3015442469, 3010626066, 3016975995, 3013053058, 3013561139, 3012759464, 3010834934, 3015200642, 3011800804, 3042823784, 3012684779, 3030978471, 9710641, 1417592, 3008729914, 3016871906, 1419937, 3013684412, 3021544150, 3010334650, 2435947, 3002297831 +74 more
- FEI number
- 3006852457, 3009974348, 3010880718, 3002807523, 3020994856, 3027115730, 3014166044, 3030479957, 3003927385, 3009243271, 3003899230, 3012188053, 3007429416, 3020034975, 3009700166, 3021376102, 3038613158, 3012062596, 3031841858, 3015442469, 3010626066, 3016975995, 3013053058, 3013561139, 3012759464, 3010834934, 3015200642, 3011800804, 3042823784, 3012684779, 3030978471, 1417592, 3008729914, 3016871906, 1419937, 3013684412, 3021544150, 3010334650, 3043515178, 3002297831 +74 more