BLOOD MONITOR BMM 10-4
FDA 510(k) clearance K831404 · decided 1984-04-25
Clearance details
- K-number
- K831404
- Device name
- BLOOD MONITOR BMM 10-4
- Applicant
- Gambro, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-02
- Decision date
- 1984-04-25
- Days to decision
- 359 days
- Clearance type
- Traditional
- Product code
- LLB
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, 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 |
|---|---|---|
| VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS (K991005) | Dayspring Medical, Inc. | 1999-06-22 |
Recalls involving this device
No recalls on record reference this clearance.