RMI RESPIRATORY GATING SYSTEM MODEL 301
FDA 510(k) clearance K854976 · decided 1986-05-07
Clearance details
- K-number
- K854976
- Device name
- RMI RESPIRATORY GATING SYSTEM MODEL 301
- Applicant
- Radiation Measurements, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-12
- Decision date
- 1986-05-07
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- IXO
- Device class
- 1
- Regulation number
- 892.1970
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Middleton, WI, 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 |
|---|---|---|
| SIEMENS ANGIOTRON (K811587) | Siemens Corp. | 1981-07-10 |
| SYNCHRONIZER #208 (K810588) | Brattle Instrument Corp. | 1981-04-10 |
| POST EXTRA SYSTOLIC POSTENTLATOR (K791959) | Medrad, Inc. | 1980-01-09 |
Recalls involving this device
No recalls on record reference this clearance.