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510(k) K803247

TRANSCUTANEOUS ELECT. NERVE STIMULATOR by Medical Research Laboratories, Inc.

K803247 is an FDA 510(k) premarket notification submitted by Medical Research Laboratories, Inc. for the device "TRANSCUTANEOUS ELECT. NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on March 20, 1981. Medical Research Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1981
Date Received
December 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Medical Research Laboratories, Inc.

  • K021168 — JUMP START, MODEL 970300 (June 26, 2002)
  • K012766 — PORTABLE INTENSIVE CARE UNIT (January 23, 2002)
  • K012030 — PORTABLE INTENSIVE CARE UNIT (September 24, 2001)
  • K010207 — PORTABLE INSTENSIVE CARE UNIT (June 14, 2001)
  • K002232 — AEDEFIBRILLATOR (December 6, 2000)
  • K000712 — PORTABLE INTENSIVE CARE UNIT, MODEL PIC (April 27, 2000)
  • K983307 — MODIFICATION TO PORTABLE INTENSIVE CARE UNIT (November 20, 1998)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K952085 — DPD DEFIBRILLATOR (June 5, 1995)
  • K935922 — 360 SLX ADVISORY DEFIBRILLATOR (December 22, 1994)

FDA data resources