VALVE, PRESSURE, DEMAND
FDA 510(k) clearance K770665 · decided 1977-04-15
Clearance details
- K-number
- K770665
- Device name
- VALVE, PRESSURE, DEMAND
- Applicant
- Mcgaw Respiratory Therapy
- Decision
- Substantially Equivalent
- Date received
- 1977-04-08
- Decision date
- 1977-04-15
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- CBD
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| IMV SYSTEM (K780340) | Lkb Instruments, Inc. | 1978-11-27 |
| VACON TM (K770369) | Diemolding Corp. | 1977-03-01 |
Recalls involving this device
No recalls on record reference this clearance.