MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
FDA 510(k) clearance K904556 · decided 1991-12-18
Clearance details
- K-number
- K904556
- Device name
- MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-10-05
- Decision date
- 1991-12-18
- Days to decision
- 439 days
- Clearance type
- Traditional
- Product code
- IOL
- Device class
- 1
- Regulation number
- 890.5380
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Jose, CA, 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 |
|---|---|---|
| PARKER MODEL PM (K950376) | Parker Treadmill Co., Inc. | 1995-09-06 |
| PARKER MODEL PE (K950377) | Parker Treadmill Co., Inc. | 1995-09-06 |
| TRACKMASTER (K925839) | Jas Manufacturing Co., Inc. | 1993-06-24 |
| RTM REHABILITATION TREADMILL, MODEL #945-200 (K930261) | Biodan Medical Systems, Ltd. | 1993-05-26 |
| TA620 TREADMILL CONTROLLER (K913518) | Siemens Burdick, Inc. | 1991-10-24 |
| T600 TREADMILL (K910867) | Siemens Burdick, Inc. | 1991-05-31 |
| MEDTRACK TREADMILL (K911751) | Quinton, Inc. | 1991-05-29 |
| ORBITER(TM) TREADMILL (K897179) | Lee-Meredith Industries, Inc. | 1990-02-15 |
| AQUATREX UNDERWATER TREADMILL SYSTEM (K895104) | Edmonds Medical Systems | 1989-12-04 |
| PACER R 9 TREADMILL (K893032) | Pacer Industries, Inc. | 1989-07-27 |
| STARTRAC (K890793) | Unisen, Inc. | 1989-03-16 |
| MODIFIED Q-SERIES OF TREADMILLS (K885062) | Quinton, Inc. | 1988-12-27 |
Recalls involving this device
No recalls on record reference this clearance.