Microstream PM35MN02-RR
Microstream PM35MN02-RR is a Class II device made by Oridion Medical 1987 Ltd., cleared under FDA 510(k) K200594 on 27 Apr 2020 and listed in FDA GUDID since 11 Sep 2020 (UDI-DI 10884521761216), 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 | Number10884521761216 | Date11 Sep 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200594 | Date27 Apr 2020 | StatusActive |
Official records
- AccessGUDID record 10884521761216
- FDA 510(k) database K200594
Across registries
- FDA 510(k) K200594 decided 27 Apr 2020 Active
- FDA GUDID UDI-DI 10884521761216 listed 11 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K200594
- Listed FDA GUDID 10884521761216
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Microstream
- Generic name
- Carbon dioxide monitor
- Model / reference
- PM35MN02-RR
- Primary DI / UDI-DI
- 10884521761216
- 510(k) Number
- FDA product code
- CCK
- GMDN term
- Carbon dioxide monitor
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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