IMV SYSTEM
FDA 510(k) clearance K780340 · decided 1978-11-27
Clearance details
- K-number
- K780340
- Device name
- IMV SYSTEM
- Applicant
- Lkb Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-01
- Decision date
- 1978-11-27
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- CBD
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- KS, 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 |
|---|---|---|
| VALVE, PRESSURE, DEMAND (K770665) | Mcgaw Respiratory Therapy | 1977-04-15 |
| VACON TM (K770369) | Diemolding Corp. | 1977-03-01 |
Recalls involving this device
No recalls on record reference this clearance.