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510(k) K780631

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

K780631 is an FDA 510(k) premarket notification submitted by New Dimensions IN Medicine, Inc. for the device "NDM INFANT ECG PACKPAD". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. New Dimensions IN Medicine, Inc. has at least 5 other 510(k) clearances on record.

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)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources