BLOOD GAS INCUBATOR #260650
FDA 510(k) clearance K823766 · decided 1983-02-18
Clearance details
- K-number
- K823766
- Device name
- BLOOD GAS INCUBATOR #260650
- Applicant
- Boekel Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-14
- Decision date
- 1983-02-18
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- JRG
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| HEATING BLOCK, WAMPOLE 37 C (K790549) | Armkel, LLC | 1979-05-03 |
| ENZAC INCUBATOR (K781501) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-03 |
Recalls involving this device
No recalls on record reference this clearance.