AG-839PA CO2 MODULE AND ACCESSORIES
FDA 510(k) clearance K944027 · decided 1994-08-31
Clearance details
- K-number
- K944027
- Device name
- AG-839PA CO2 MODULE AND ACCESSORIES
- Applicant
- Nihon Kohden America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-17
- Decision date
- 1994-08-31
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- BXO
- Device class
- 1
- Regulation number
- 868.2900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, 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 |
|---|---|---|
| POLY G PHYSIOLOGICAL DATA RECORDER (K897107) | Cns, Inc. | 1990-03-12 |
Recalls involving this device
No recalls on record reference this clearance.