LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
FDA 510(k) clearance K781454 · decided 1978-09-20
Clearance details
- K-number
- K781454
- Device name
- LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA
- Applicant
- Union Carbide Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-08-22
- Decision date
- 1978-09-20
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- CHW
- Device class
- 2
- Regulation number
- 862.1145
- 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 |
|---|---|---|
| CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV (K192730) | Biosystems S.A. | 2020-09-09 |
| CALCIUM GEN. 2 (K113521) | Roche Diagnostics | 2012-05-08 |
Recalls involving this device
No recalls on record reference this clearance.