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510(k) K800087

ULTRASONIC FLOWMETER by The Perkin-Elmer Corp. — Product Code BXP

K800087 is an FDA 510(k) premarket notification submitted by The Perkin-Elmer Corp. for the device "ULTRASONIC FLOWMETER". The FDA issued a decision of Substantially Equivalent on March 19, 1980. The device falls under product code BXP (Transducer, Gas Flow), a Class I device regulated under 21 CFR 868.2885. The Perkin-Elmer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1980
Date Received
January 14, 1980
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 The Perkin-Elmer Corp.

  • K935666 — PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (April 26, 1994)
  • K900828 — PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. (April 9, 1990)
  • K884864 — PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO (February 10, 1989)
  • K884886 — MODEL 250 LIQUID CHROMOTAGRAPHY PUMP (February 2, 1989)
  • K872737 — PERKIN-ELMER LC235 DIODE ARRAY DETECTOR (September 18, 1987)
  • K872464 — ION TRAP DETECTOR (ITD) (August 11, 1987)
  • K871550 — PFI-20 POLARIZING FLUORIMETER (July 1, 1987)
  • K872122 — 8000 SERIES GAS CHROMATOGRAPHS (June 17, 1987)
  • K870661 — LIFEWATCH PLUS (March 9, 1987)
  • K862605 — MODULAR MASS SPECTROMETER (M.S.) (August 13, 1986)

Other clearances for product code BXP

  • K936141 — UNIPOWER RECHARGEABLE BATTERY PACK (March 31, 1994)
  • K920360 — TIMOX OXYGEN TIMER (August 3, 1992)
  • K832678 — PHONATORY FUNCTION ANALYZER PS-77 (March 7, 1984)
  • 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)

FDA data resources