MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
FDA 510(k) clearance K850761 · decided 1985-09-19
Clearance details
- K-number
- K850761
- Device name
- MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C
- Applicant
- Medicor USA , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-25
- Decision date
- 1985-09-19
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- BZN
- Device class
- 1
- Regulation number
- 868.6175
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Columbus, OH, 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 |
|---|---|---|
| ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (K924373) | Instrumed, Inc. | 1992-11-25 |
| CART, EMERGENCY, CARDIOPULMONARY (K872558) | Nico Metal Products Corp. | 1987-07-24 |
| SERVO CART 170 (K840264) | Siemens Elema AB | 1984-02-04 |
| RMP INTUBATION EQUIP. STORAGE TRAY (K832697) | Rmp Co. | 1983-12-27 |
| PORTABLE OPERAT. RM. MONITORS HS30/40 (K832356) | Medtel Pty. , Ltd. | 1983-10-28 |
| CRASH CART (K832355) | Quinton, Inc. | 1983-10-28 |
| EMERGENCY CART (K772320) | Physio-Control Corp. | 1978-01-03 |
Recalls involving this device
No recalls on record reference this clearance.