GENERATOR, R-WAVE
FDA 510(k) clearance K790213 · decided 1979-03-22
Clearance details
- K-number
- K790213
- Device name
- GENERATOR, R-WAVE
- Applicant
- Amr Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-30
- Decision date
- 1979-03-22
- Days to decision
- 51 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
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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 |
|---|---|---|
| VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) (K853737) | Capintec, Inc. | 1986-02-13 |
| NUCLEAR STETHOSCOPE (K780510) | Bios, Inc. | 1978-04-18 |
Recalls involving this device
No recalls on record reference this clearance.