Midmark M11-040 / 9A682001
Midmark M11-040 / 9A682001 (M11-040-DL) is a Class I device made by Midmark Corporation, cleared under FDA 510(k) K163337 on 31 Aug 2017 and listed in FDA GUDID since 28 Jul 2020 (UDI-DI 00841709118227), active as of 22 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 | Number00841709118227 | Date28 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163337 | Date31 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00841709118227
- FDA 510(k) database K163337
Across registries
- FDA 510(k) K163337 decided 31 Aug 2017 Active
- FDA GUDID UDI-DI 00841709118227 listed 28 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K163337
- Listed FDA GUDID 00841709118227
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Midmark
- Generic name
- Medical equipment non-clinical data monitoring software
- Model / Ref / Catalog
- M11-040 / 9A682001, M11-040-DL
- Primary DI / UDI-DI
- 00841709118227
- 510(k) Number
- FDA product code
- OUG, FLE
- GMDN term
- Medical equipment non-clinical data monitoring software
- Device class
- Class I
- Regulation number
- 880.6310, 880.6880
- GUDID distribution status
- In Commercial Distribution
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