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510(k) K854537

HEADSTRAP by Life Design Systems, Inc. — Product Code BTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1985
Date Received
November 13, 1985
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 Life Design Systems, Inc.

  • K913714 — MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) (December 1, 1992)
  • K885313 — HUMIDI-FLEX TM (October 11, 1989)
  • K893030 — CHILD SIZE - FILTER FLEX (TM) (September 18, 1989)
  • K892862 — FLEX-CUP PERCUSSOR (May 25, 1989)
  • K892221 — PULMONARY RESUSCITATOR, MODIFICATION (May 18, 1989)
  • K890011 — OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING (March 20, 1989)
  • K890108 — MODIFIED CUSHION-FLEX(TM) (January 24, 1989)
  • K884387 — CUSHION FLEX(TM) (November 17, 1988)
  • K884068 — PULMANEX TM (NEO-NATAL SIZE) (November 16, 1988)
  • K873179 — HEATER WIRE BREATHING CIRCUIT (March 31, 1988)

Other clearances for product code BTK

  • K944949 — GENERAL ANESTHESIA SYSTEM (November 14, 1994)
  • K914335 — STRAP, HEAD, GAS MASK (April 2, 1992)
  • K853573 — MEDIPART FACE MASK HEADSTRAP MP-9100 (October 29, 1985)
  • K831008 — HEAD STRAP (May 9, 1983)
  • K810991 — HEADSTRAP (April 29, 1981)