VACON TM
FDA 510(k) clearance K770369 · decided 1977-03-01
Clearance details
- K-number
- K770369
- Device name
- VACON TM
- Applicant
- Diemolding Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-24
- Decision date
- 1977-03-01
- Days to decision
- 5 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 |
| VALVE, PRESSURE, DEMAND (K770665) | Mcgaw Respiratory Therapy | 1977-04-15 |
Recalls involving this device
No recalls on record reference this clearance.