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510(k) K822077

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

K822077 is an FDA 510(k) premarket notification submitted by New Dimensions IN Medicine, Inc. for the device "RESPIRATION MONITOR TYPE MR-10". The FDA issued a decision of Substantially Equivalent on October 6, 1982. The device falls under product code FLS (Monitor, Apnea, Facility Use), a Class II device regulated under 21 CFR 868.2377. New Dimensions IN Medicine, Inc. has at least 5 other 510(k) clearances on record.

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.

  • K920677 — CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION (April 21, 1992)
  • K832145 — MONOBLOCK PROSTOPERATIVE TENS ELECTRODE (July 19, 1983)
  • 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

  • K011597 — SMARTMONITOR 2, MODEL 4000 (January 11, 2002)
  • 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)

FDA data resources