VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
FDA 510(k) clearance K853737 · decided 1986-02-13
Clearance details
- K-number
- K853737
- Device name
- VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
- Applicant
- Capintec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-06
- Decision date
- 1986-02-13
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- IYY
- Device class
- 1
- Regulation number
- 892.1410
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pittsburgh, PA, 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 |
|---|---|---|
| GENERATOR, R-WAVE (K790213) | Amr Co. | 1979-03-22 |
| NUCLEAR STETHOSCOPE (K780510) | Bios, Inc. | 1978-04-18 |
Recalls involving this device
No recalls on record reference this clearance.