NUCLEAR STETHOSCOPE
FDA 510(k) clearance K780510 · decided 1978-04-18
Clearance details
- K-number
- K780510
- Device name
- NUCLEAR STETHOSCOPE
- Applicant
- Bios, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-30
- Decision date
- 1978-04-18
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- IYY
- Device class
- 1
- Regulation number
- 892.1410
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bios
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 |
|---|---|---|
| VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) (K853737) | Capintec, Inc. | 1986-02-13 |
| GENERATOR, R-WAVE (K790213) | Amr Co. | 1979-03-22 |
Recalls involving this device
No recalls on record reference this clearance.