FADASIS MEDICAL FM-1 NO BLENDER
FDA 510(k) clearance K011874 · decided 2001-07-20
Clearance details
- K-number
- K011874
- Device name
- FADASIS MEDICAL FM-1 NO BLENDER
- Applicant
- Fadasis Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-15
- Decision date
- 2001-07-20
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- MRO
- Device class
- 2
- Regulation number
- 868.5165
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Middleton, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INOBLENDER (K122689) | Ino Therapeutics | 2012-11-07 |
| INO THERAPEUTICS INOBLENDER, MODEL 10004 (K052663) | Ino Therapeutics | 2005-11-04 |
| FADASSI MEDICAL FM-1 NO BLENDER (K003665) | Fadasis Medical, Inc. | 2001-02-23 |
Recalls involving this device
No recalls on record reference this clearance.