Peritron+ PRN04000
by Laborie Medical Technologies Canada ULC
Peritron+ PRN04000 is a Class II device made by Laborie Medical Technologies Canada ULC, cleared under FDA 510(k) K983052 on 19 Oct 1998 and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00627825006361), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00627825006361 | Date28 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983052 | Date19 Oct 1998 | StatusActive |
Official records
- AccessGUDID record 00627825006361
- FDA 510(k) database K983052
Across registries
- FDA 510(k) K983052 decided 19 Oct 1998 Active
- FDA GUDID UDI-DI 00627825006361 listed 28 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K983052
- Listed FDA GUDID 00627825006361
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Peritron+
- Generic name
- Perineometer
- Model / reference
- PRN04000
- Primary DI / UDI-DI
- 00627825006361
- 510(k) Number
- FDA product code
- HIR
- GMDN term
- Perineometer
- Device class
- Class II
- Regulation number
- 884.1425
- GUDID distribution status
- In Commercial Distribution
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