Intracranial Pressure & Temperature Monitoring Kit
Neurology · 21 CFR 882.1620
Open FDA's page for this record- Third party flag
- N
- Life sustain support flag
- N
- Gmp exempt flag
- N
- Summary malfunction reporting
- Ineligible
- Product code
- PSP
- Review panel
- NE
- Medical specialty
- NE
- Device name
- Intracranial Pressure & Temperature Monitoring Kit
- Medical specialty description
- Neurology
- Device class
- 2
- Regulation number
- 882.1620
- Implant flag
- N
- Submission type ID
- 7
- Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Harmonized identifiers (openFDA)
- Registration number
- 9616088, 1643817, 3009888344, 3004111573, 3002821232, 1422634, 2023988, 1061124, 1423537, 3007329020, 3042989733
- FEI number
- 3002902735, 1000514656, 1643817, 3009888344, 3004111573, 3002821232, 2023988, 1000512168, 3007329020, 3001236905, 3042989733