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510(k) K822077

RESPIRATION MONITOR TYPE MR-10 by New Dimensions IN Medicine, Inc. — Product Code FLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1982
Date Received
July 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type

Other clearances by New Dimensions IN Medicine, Inc.

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  • K780631 — NDM INFANT ECG PACKPAD (May 3, 1978)
  • K780405 — INFANT ELECTROSURGICAL GROUNDING PAD (April 5, 1978)
  • K771749 — AMALGAM DISPENSER (September 28, 1977)

Other clearances for product code FLS

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  • K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR (January 12, 2000)
  • K962865 — REMBRANDT SYSTEM (October 25, 1996)
  • K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY O (February 2, 1996)
  • K894973 — RESPITRACE PLUS (October 30, 1989)
  • K832999 — RESPIRATION MONITOR (February 13, 1984)
  • K830778 — MONITORING KIT AMK-1 (October 14, 1983)
  • K821721 — CLINICAL DATA APNEA DETECTOR (July 13, 1982)
  • K820943 — SYSTEM I INFANT MONITORING SYS (May 3, 1982)
  • K810153 — VENTILATORY EFFORT MONITOR (February 9, 1981)