NPP — Reprocessed Blood Pressure Cuff Class II
FDA product code NPP covers "Reprocessed Blood Pressure Cuff", a Class II medical device regulated under 21 CFR 870.1120. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NPP
- Device Class
- Class II
- Regulation Number
- 870.1120
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K032821 | hygia health services | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | December 5, 2003 |