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510(k) K970507

PEAK FLOW METER by Intl. Medical, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
February 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

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  • K942068 — AMERICAN CATHETER SPHINCTEROTOME (June 24, 1994)
  • K930410 — DURHAM; LUER LOCK EXTENSION SET (September 3, 1993)
  • K930406 — DURHAM; MIN BORE LUER LOCK EXTENSION SET (September 3, 1993)
  • K923200 — AMCATH DISPOSABLE CYTOLOGY BRUSH (December 7, 1992)
  • K915142 — AMCATH DISPOSABLE BIOPSY FORCEPS (January 10, 1992)
  • K912927 — AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE (September 19, 1991)
  • K912605 — AMCATH DISPOSABLE MICRO SCISSORS (July 11, 1991)

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