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510(k) K883158

RESPIRATORY AIRWAY TUBE MONITOR (RATM) by Vascucare, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1989
Date Received
July 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Vascucare, Inc.

  • K890047 — VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM (June 20, 1989)
  • K881780 — VASCUCARE ANGIOPUMP (September 28, 1988)

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