OptoMonitor 3
Opsens, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Quebec
- Advisory committee description
- Cardiovascular
- Address 1
- 750 Blvd. Du Parc Technologique
- Statement or summary
- Summary
- Product code
- DXO
- Zip code
- G1P 4S3
- Applicant
- Opsens, Inc.
- Decision date
- 2025-02-12
- Decision code
- SESE
- Country code
- CA
- Device name
- OptoMonitor 3
- Advisory committee
- CV
- Contact
- Marc Chaunet
- K number
- K241418
- Date received
- 2024-05-20
- Review advisory committee
- CV
- Postal code
- G1P 4S3
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Transducer, Pressure, Catheter Tip
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.2870
- Device class
- 2
- Registration number
- 2134265, 3013943846, 9611665, 3009600098, 2648045, 3030446844, 3032916632, 3004122598, 1000121056, 3008061490, 2124215, 2133928, 3030733800, 9615817, 1054811, 1043214, 2183744, 3009564766, 9612051, 3005232773, 3000126629, 3008363989, 3004832480, 3010273872, 2134285, 3009490946, 3004748528, 3005334138, 2024168, 3017636737, 3011469355, 9681260, 3004111573, 1644312, 3043226252, 2939520, 3007029079, 3015173212, 3010432890, 3012494290 +20 more
- FEI number
- 3013943846, 2648045, 3009600098, 3030446844, 3032916632, 3004122598, 1000121056, 3008061490, 3002806565, 2124215, 3001726808, 3030733800, 1043214, 2183744, 1000121130, 3002807095, 3009564766, 3005232773, 3000126629, 3008363989, 3004832480, 3010273872, 3003040625, 3009490946, 3007029079, 3004748528, 1000306431, 3005334138, 2024168, 1625382, 3017636737, 3011469355, 3004111573, 3043226252, 3002095335, 3002807111, 2939520, 3015173212, 3010432890, 3012494290 +20 more