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510(k) K001318

CPAP SYSTEM, MODEL 102001 by Sims Portex, Inc. — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2000
Date Received
April 26, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

Other clearances by Sims Portex, Inc.

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  • K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PR (July 12, 2001)
  • K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER (February 5, 2001)
  • K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT (December 14, 2000)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)
  • K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK (April 28, 2000)
  • K000628 — WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET- (March 13, 2000)
  • K994275 — SIMS PORTEX ANESTHESIA CATHETER (February 22, 2000)
  • K991861 — 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MA (January 18, 2000)

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