Ez Pump
FDA 510(k) K926446 · Alphamed, Inc.
510(k) numberK926446
Submission
- Device name
- Ez Pump
- Applicant
- Alphamed, Inc.
Duluth, GA, US - Received
- December 23, 1992
- Decision date
- September 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRW – Scale, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2720
- Specialty
- General Hospital
Other 510(k)s with product code FRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955357 | Olympic Smart Scale Model 50/50RAFRW · Traditional | Olympic Medical Corp. | 01/30/1996SE |
| K955177 | Olympic Smart ScaleFRW · Traditional | Olympic Medical Corp. | 12/14/1995SE |
| K954846 | Olympic Smart ScaleFRW · Traditional | Olympic Medical Corp. | 12/14/1995SE |
| K952649 | Warm-ScaleFRW · Traditional | Olympic Medical Corp. | 08/15/1995SE |
| K943587 | Advanced In-Bed Weigh SystemFRW · Traditional | Future Systems, Inc. | 09/22/1994SE |
| K932572 | Digital Baby Scale Model BLB-12FRW · Traditional | Tanita Corp. of America | 11/16/1993SE |
| K926174 | Model 9100 H.R. Infant ScaleFRW · Traditional | Acme Medical Scale Co. | 10/25/1993SE |
| K926059 | 3M Model 200RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K926058 | 3M Model 280RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K930626 | Sanitas Patient ScaleFRW · Traditional | Dutton-Lainson Co. | 08/06/1993SE |
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Questions and answers
When was Ez Pump cleared by the FDA?
Ez Pump (K926446) received a 510(k) decision of Substantially Equivalent on September 27, 1993, 278 days after the submission was received.
What is the product code of K926446?
The FDA product code is FRW – Scale, Patient, a Class I (low risk) device regulated under 21 CFR 880.2720.