MPQ-42
FDA 510(k) clearance K934944 · decided 1993-12-15
Clearance details
- K-number
- K934944
- Device name
- MPQ-42
- Applicant
- Elema-Schonander, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-18
- Decision date
- 1993-12-15
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- IZP
- Device class
- 2
- Regulation number
- 892.1870
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Schaumburg, 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 |
|---|---|---|
| PHILIPS ANGIOPRO (K911888) | Philips Medical Systems North America, Inc. | 1991-10-15 |
| PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM (K904144) | Mallinckrodt Group, Inc. | 1990-12-13 |
| SEP 90 (K904103) | Elema-Schonander, Inc. | 1990-11-20 |
| OMNIPLANE 200 FILM CHANGER SYSTEM (K874451) | Medrad, Inc. | 1988-02-11 |
| THE CSE FILM CHANGER SYSTEM (K854251) | Changer Service & Engineering, Inc. | 1985-10-28 |
| SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (K842903) | Elema-Schonander, Inc. | 1984-08-21 |
| MAXIMAX - 4 (K841649) | Cgr Medical Corp. | 1984-06-05 |
| LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (K841732) | Sybron Corp. | 1984-06-05 |
| SEP PROGRAMMER SEP-M/SINGLE-PLANE & (K840389) | Elema-Schonander, Inc. | 1984-02-21 |
Recalls involving this device
No recalls on record reference this clearance.