INO THERAPEUTICS INOBLENDER, MODEL 10004
FDA 510(k) clearance K052663 · decided 2005-11-04
Clearance details
- K-number
- K052663
- Device name
- INO THERAPEUTICS INOBLENDER, MODEL 10004
- Applicant
- Ino Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 2005-09-27
- Decision date
- 2005-11-04
- Days to decision
- 38 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 |
| FADASIS MEDICAL FM-1 NO BLENDER (K011874) | Fadasis Medical, Inc. | 2001-07-20 |
| FADASSI MEDICAL FM-1 NO BLENDER (K003665) | Fadasis Medical, Inc. | 2001-02-23 |
Recalls involving this device
No recalls on record reference this clearance.