3M Model 280RT Rate Taper Infusion Pump
FDA 510(k) K926058 · 3M Health Care, Ltd.
510(k) numberK926058
Submission
- Device name
- 3M Model 280RT Rate Taper Infusion Pump
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- December 1, 1992
- Decision date
- August 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K926446 | Ez PumpFRW · Traditional | Alphamed, Inc. | 09/27/1993SE |
| K926059 | 3M Model 200RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K930626 | Sanitas Patient ScaleFRW · Traditional | Dutton-Lainson Co. | 08/06/1993SE |
More from Dutton-Lainson Co.
| 510(k) | Device | Decision |
|---|---|---|
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 04/19/1996SE |
| K926364 | Attest Brand Rapid Readout Biological Ind. #129XFRC · Traditional | 03/31/1995SE |
| K941534 | Modular VS-22 Cemented Femoral Hip SystemKWY · Traditional | 03/06/1995SE |
| K941748 | Steri-Vac Gas Sterilizer Model 8XLFLF · Traditional | 12/02/1994SE |
| K930681 | 3M Prevention Fabric Surgical Gown #78XXFYA · Traditional | 02/10/1994SE |
| K932307 | 3M Maxi-Driver II Dbattery Powered SystemKIJ · Traditional | 01/07/1994SE |
| K932422 | 3M Tegaderm HP Transparent DressingKGX · Traditional | 12/27/1993SE |
| K932446 | Injection SiteFPA · Traditional | 11/29/1993SE |
| K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen SaturatioDRY · Traditional | 11/10/1993SE |
| K933006 | Avi Infusion Pumps, Additional Intended UseFRN · Traditional | 10/25/1993SE |
Questions and answers
When was 3M Model 280RT Rate Taper Infusion Pump cleared by the FDA?
3M Model 280RT Rate Taper Infusion Pump (K926058) received a 510(k) decision of Substantially Equivalent on August 16, 1993, 258 days after the submission was received.
What is the product code of K926058?
The FDA product code is FRW – Scale, Patient, a Class I (low risk) device regulated under 21 CFR 880.2720.