EZ PUMP
FDA 510(k) clearance K926446 · decided 1993-09-27
Clearance details
- K-number
- K926446
- Device name
- EZ PUMP
- Applicant
- Alphamed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-23
- Decision date
- 1993-09-27
- Days to decision
- 278 days
- Clearance type
- Traditional
- Product code
- FRW
- Device class
- 1
- Regulation number
- 880.2720
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Duluth, GA, 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 |
|---|---|---|
| OLYMPIC SMART SCALE MODEL 50/50RA (K955357) | Olympic Medical Corp. | 1996-01-30 |
| OLYMPIC SMART SCALE (K954846) | Olympic Medical Corp. | 1995-12-14 |
| OLYMPIC SMART SCALE (K955177) | Olympic Medical Corp. | 1995-12-14 |
| WARM-SCALE (K952649) | Olympic Medical Corp. | 1995-08-15 |
| ADVANCED IN-BED WEIGH SYSTEM (K943587) | Future Systems, Inc. | 1994-09-22 |
| DIGITAL BABY SCALE MODEL BLB-12 (K932572) | Tanita Corp. of America | 1993-11-16 |
| MODEL 9100 H.R. INFANT SCALE (K926174) | Acme Medical Scale Co. | 1993-10-25 |
| 3M MODEL 200RT RATE TAPER INFUSION PUMP (K926059) | 3M Health Care, Ltd. | 1993-08-16 |
| 3M MODEL 280RT RATE TAPER INFUSION PUMP (K926058) | 3M Health Care, Ltd. | 1993-08-16 |
| SANITAS PATIENT SCALE (K930626) | Dutton-Lainson Co. | 1993-08-06 |
| DISETRONIC DOLOMAT PUMP (K920063) | Disetronic Medical Systems | 1993-08-03 |
| DETECTO MODEL 6700 SERIES (K924847) | Cardinal Scale Mfg. Co. | 1993-05-24 |
Recalls involving this device
No recalls on record reference this clearance.