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510(k) K853475

GRAM-MA NEONATAL SC by Kentec Medical, Inc. — Product Code FRW

K853475 is an FDA 510(k) premarket notification submitted by Kentec Medical, Inc. for the device "GRAM-MA NEONATAL SC". The FDA issued a decision of Substantially Equivalent on September 5, 1985. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Kentec Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
August 20, 1985
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 Kentec Medical, Inc.

  • K120272 — AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET (February 17, 2012)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)
  • K050443 — ACCU-LEAD (September 2, 2005)
  • K970686 — ACCUTEMP-PROBE (August 25, 1997)
  • K960080 — ACCUTEMP PROBE (May 1, 1996)

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)
  • K926446 — EZ PUMP (September 27, 1993)
  • K926058 — 3M MODEL 280RT RATE TAPER INFUSION PUMP (August 16, 1993)
  • K926059 — 3M MODEL 200RT RATE TAPER INFUSION PUMP (August 16, 1993)

FDA data resources