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510(k) K832678

PHONATORY FUNCTION ANALYZER PS-77 by Kells Medical, Inc. — Product Code BXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1984
Date Received
August 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Gas Flow
Device Class
Class I
Regulation Number
868.2885
Review Panel
AN
Submission Type

Other clearances by Kells Medical, Inc.

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  • K890095 — PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
  • K861972 — DERMISTRIP (June 27, 1986)
  • K844463 — DERMIDRESS (January 8, 1985)
  • K844072 — DERMIZIP SKIN CLOSURE DEVICE (November 5, 1984)
  • K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)
  • K823118 — SAY (January 7, 1983)
  • K823227 — IMPEDANCE METER ON-1 (November 22, 1982)

Other clearances for product code BXP

  • K936141 — UNIPOWER RECHARGEABLE BATTERY PACK (March 31, 1994)
  • K920360 — TIMOX OXYGEN TIMER (August 3, 1992)
  • K800087 — ULTRASONIC FLOWMETER (March 19, 1980)
  • K781039 — OXY-ON DIGITAL OXYGEN TIMER (August 31, 1978)
  • K770424 — OXYGEN TWMER, MODEL SST (March 16, 1977)
  • K761260 — ARIZONA OXYGEN TIMER DEVICE (December 16, 1976)