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510(k) K881670

ACCUTEMP PLUS by Sentry Medical Products, Inc. — Product Code FMT

K881670 is an FDA 510(k) premarket notification submitted by Sentry Medical Products, Inc. for the device "ACCUTEMP PLUS". The FDA issued a decision of Substantially Equivalent on November 22, 1988. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Sentry Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1988
Date Received
April 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

Other clearances by Sentry Medical Products, Inc.

  • K962122 — SENTRY RADIOTRANSLUCENT ECG ELECTRODES (July 24, 1996)
  • K955636 — SENTRY DISPOSABLE DISPERSIVE ELECTRODE (March 27, 1996)
  • K942827 — SENTRY INSERTION TRAY (November 2, 1994)
  • K934000 — SENTRY AQUEOUS GEL ECG ELECTRODES (August 30, 1994)
  • K935098 — BABY BOARD (February 15, 1994)
  • K933603 — LEADWIRE (January 18, 1994)
  • K932704 — PATIENT CABLE (December 27, 1993)
  • K881343 — DURADERM BUTTERFLY (May 4, 1988)
  • K851522 — DIAGNOSTIC ECG DISPOSABLE ELECTRODE (October 24, 1985)
  • K853552 — SENTRY FLEXIBLE TENS (September 26, 1985)

Other clearances for product code FMT

  • K243606 — Babyroo TN300 (January 17, 2025)
  • K230278 — Babyroo TN300 (May 30, 2023)
  • K213551 — Giraffe Omnibed Carestation CS1 (March 2, 2022)
  • K201628 — Panda iRes Warmer, Giraffe Warmer (February 12, 2021)
  • K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su (April 2, 2020)
  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173516 — NuBorne Infant Warmer (August 17, 2018)
  • K123309 — GIRAFFE AND PANDA WARMERS (February 5, 2013)
  • K120642 — RESUSCITAIRE WITH AUTOBREATH (November 2, 2012)
  • K122267 — GIRAFFE AND PANDA WARMERS (October 2, 2012)

FDA data resources