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510(k) K914335

STRAP, HEAD, GAS MASK by Vital Signs, Inc. — Product Code BTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1992
Date Received
September 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strap, Head, Gas Mask
Device Class
Class I
Regulation Number
868.5560
Review Panel
AN
Submission Type

Other clearances by Vital Signs, Inc.

  • K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
  • K041309 — IMASK TM (June 30, 2004)
  • K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
  • K022402 — DISPOSABLE PRESSURE MANOMETER (August 22, 2002)
  • K021315 — SURE-LOK (August 21, 2002)
  • K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
  • K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
  • K000441 — BODYGUARD (April 11, 2000)
  • K994044 — CLEEN-ABLE (February 25, 2000)
  • K990412 — CUFF-ABLE PLUS (September 1, 1999)

Other clearances for product code BTK

  • K944949 — GENERAL ANESTHESIA SYSTEM (November 14, 1994)
  • K854537 — HEADSTRAP (December 3, 1985)
  • K853573 — MEDIPART FACE MASK HEADSTRAP MP-9100 (October 29, 1985)
  • K831008 — HEAD STRAP (May 9, 1983)
  • K810991 — HEADSTRAP (April 29, 1981)