ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
FDA 510(k) clearance K914887 · decided 1992-05-08
Clearance details
- K-number
- K914887
- Device name
- ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
- Applicant
- Mallinckrodt Medical
- Decision
- Substantially Equivalent
- Date received
- 1991-10-30
- Decision date
- 1992-05-08
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- FRQ
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- St Louis, MO, 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 |
|---|---|---|
| ICAN GT DRAINAGE BAG (K914530) | Icn Pharmaceuticals, Inc. | 1991-12-18 |
| PEDIWET=GUAZE IMPREGNATED WITH PETROL (K802007) | Pollak (Intl.), Ltd. | 1980-09-26 |
Recalls involving this device
No recalls on record reference this clearance.