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510(k) K926058

3M MODEL 280RT RATE TAPER INFUSION PUMP by 3M Health Care, Ltd. — Product Code FRW

K926058 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "3M MODEL 280RT RATE TAPER INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on August 16, 1993. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1993
Date Received
December 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Patient
Device Class
Class I
Regulation Number
880.2720
Review Panel
HO
Submission Type

Other clearances by 3M Health Care, Ltd.

  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (March 31, 1995)
  • K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (March 6, 1995)
  • K941748 — STERI-VAC GAS STERILIZER MODEL 8XL (December 2, 1994)
  • K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX (February 10, 1994)
  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932422 — 3M TEGADERM HP TRANSPARENT DRESSING (December 27, 1993)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933005 — AVI MODEL 600 SYRINGE PUMP (October 25, 1993)

Other clearances for product code FRW

  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K955177 — OLYMPIC SMART SCALE (December 14, 1995)
  • K954846 — OLYMPIC SMART SCALE (December 14, 1995)
  • K952649 — WARM-SCALE (August 15, 1995)
  • K943587 — ADVANCED IN-BED WEIGH SYSTEM (September 22, 1994)
  • K932572 — DIGITAL BABY SCALE MODEL BLB-12 (November 16, 1993)
  • K926174 — MODEL 9100 H.R. INFANT SCALE (October 25, 1993)
  • K926446 — EZ PUMP (September 27, 1993)
  • K926059 — 3M MODEL 200RT RATE TAPER INFUSION PUMP (August 16, 1993)
  • K930626 — SANITAS PATIENT SCALE (August 6, 1993)

FDA data resources