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510(k) K810991

HEADSTRAP by Respironics, Inc. — Product Code BTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
April 13, 1981
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

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Other clearances for product code BTK

  • K944949 — GENERAL ANESTHESIA SYSTEM (November 14, 1994)
  • K914335 — STRAP, HEAD, GAS MASK (April 2, 1992)
  • K854537 — HEADSTRAP (December 3, 1985)
  • K853573 — MEDIPART FACE MASK HEADSTRAP MP-9100 (October 29, 1985)
  • K831008 — HEAD STRAP (May 9, 1983)