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510(k) K926446

EZ PUMP by Alphamed, Inc. — Product Code FRW

K926446 is an FDA 510(k) premarket notification submitted by Alphamed, Inc. for the device "EZ PUMP". The FDA issued a decision of Substantially Equivalent on September 27, 1993. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Alphamed, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1993
Date Received
December 23, 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 Alphamed, Inc.

  • K190210 — Tear Pool Dissolvable Punctum Plugs (October 24, 2019)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K990321 — ALPHAMED GEMINI SENSOR, SNORING SENSOR (June 1, 1999)

Other clearances for product code FRW

  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954846 — OLYMPIC SMART SCALE (December 14, 1995)
  • K955177 — 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)
  • K926059 — 3M MODEL 200RT RATE TAPER INFUSION PUMP (August 16, 1993)
  • K926058 — 3M MODEL 280RT RATE TAPER INFUSION PUMP (August 16, 1993)
  • K930626 — SANITAS PATIENT SCALE (August 6, 1993)

FDA data resources