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510(k) K843984

PM-80 PULMOTESTER by Future Impex Corp. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
October 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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  • K854679 — PHOTIC-100 SPECTROPHOTOMETER (February 20, 1986)
  • K843934 — MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT (November 20, 1984)
  • K843700 — ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- (October 24, 1984)
  • K832430 — FUKUNDA SANGYO UNITS ELECTRONIC SPIRO (September 29, 1983)

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