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510(k) K780631

NDM INFANT ECG PACKPAD by New Dimensions IN Medicine, Inc. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1978
Date Received
April 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
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)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (October 6, 1982)
  • K780405 — INFANT ELECTROSURGICAL GROUNDING PAD (April 5, 1978)
  • K771749 — AMALGAM DISPENSER (September 28, 1977)

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