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510(k) K032491

ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR by Imagyn Medical Technologies, Inc. — Product Code DSB

Clearance Details

Decision
SESU ()
Decision Date
September 4, 2003
Date Received
August 12, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

Other clearances by Imagyn Medical Technologies, Inc.

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  • K991526 — ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 (June 17, 1999)
  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K980291 — IMPOWER EXTERNAL VACUUM SYSTEM (March 11, 1998)
  • K974173 — ERECAID SYSTEM/STAY EREC SYSTEM (February 25, 1998)

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