°M Warmer System
FDA 510(k) clearance K232107 · decided 2024-05-31
Clearance details
- K-number
- K232107
- Device name
- °M Warmer System
- Applicant
- Mequ A/S
- Decision
- Substantially Equivalent
- Date received
- 2023-07-14
- Decision date
- 2024-05-31
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kobenhavn N, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mequ A/S
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.