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510(k) K012706

IM2001 PULSE OXIMETER by Imagyn Medical Technologies, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Imagyn Medical Technologies, Inc.

  • K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (September 4, 2003)
  • K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (December 3, 2001)
  • 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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