POLY G PHYSIOLOGICAL DATA RECORDER
FDA 510(k) clearance K897107 · decided 1990-03-12
Clearance details
- K-number
- K897107
- Device name
- POLY G PHYSIOLOGICAL DATA RECORDER
- Applicant
- Cns, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-21
- Decision date
- 1990-03-12
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- BXO
- Device class
- 1
- Regulation number
- 868.2900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Eden Prairie, MN, 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 |
|---|---|---|
| AG-839PA CO2 MODULE AND ACCESSORIES (K944027) | Nihon Kohden America, Inc. | 1994-08-31 |
Recalls involving this device
No recalls on record reference this clearance.