PORTABLE INFANT VENTILATOR
FDA 510(k) clearance K771368 · decided 1977-08-04
Clearance details
- K-number
- K771368
- Device name
- PORTABLE INFANT VENTILATOR
- Applicant
- Cavitron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-07-25
- Decision date
- 1977-08-04
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- FOC
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cavitron Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PREMIE U-BAG URINE SPECIMEN COLLECTOR (K950176) | Hollister, Inc. | 1995-02-07 |
| RIMECO MIDSTREAM URINE COLLECTOR (K943752) | Rimeco Products, Inc. | 1994-11-01 |
| BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE (K911329) | C.R. Bard, Inc. | 1991-05-28 |
Recalls involving this device
No recalls on record reference this clearance.