POST EXTRA SYSTOLIC POSTENTLATOR
FDA 510(k) clearance K791959 · decided 1980-01-09
Clearance details
- K-number
- K791959
- Device name
- POST EXTRA SYSTOLIC POSTENTLATOR
- Applicant
- Medrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-10-01
- Decision date
- 1980-01-09
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- IXO
- Device class
- 1
- Regulation number
- 892.1970
- 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 |
|---|---|---|
| RMI RESPIRATORY GATING SYSTEM MODEL 301 (K854976) | Radiation Measurements, Inc. | 1986-05-07 |
| SIEMENS ANGIOTRON (K811587) | Siemens Corp. | 1981-07-10 |
| SYNCHRONIZER #208 (K810588) | Brattle Instrument Corp. | 1981-04-10 |
Recalls involving this device
No recalls on record reference this clearance.