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510(k) K791336

BUCKS NEUROLOGICAL HAMMER by Amdia Medical Products — Product Code GWZ

K791336 is an FDA 510(k) premarket notification submitted by Amdia Medical Products for the device "BUCKS NEUROLOGICAL HAMMER". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code GWZ (Percussor), a Class I device regulated under 21 CFR 882.1700. Amdia Medical Products has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
July 20, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor
Device Class
Class I
Regulation Number
882.1700
Review Panel
NE
Submission Type

Other clearances by Amdia Medical Products

  • K791333 — BOWLES STETHOSCOPE (August 10, 1979)
  • K791338 — DUAL HEAD STETHOSCOPE (August 10, 1979)
  • K791334 — MULTISCOPE (August 10, 1979)
  • K791335 — NURSESCOPE (August 10, 1979)
  • K791337 — TAYLOR NEUROLOGICAL HAMMER (August 3, 1979)

Other clearances for product code GWZ

  • K891571 — PERCUSSION HAMMER (March 31, 1989)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K851748 — 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE (June 13, 1985)
  • K840314 — CAT 10-NEUROLOGY DEVICE (February 23, 1984)
  • K834170 — OP-CON SURG. INSTRUMENT #10 (February 23, 1984)
  • K834178 — H.R. JAKOBI SURG. INSTR. #10 34/36 (February 23, 1984)
  • K810054 — RICA (DIAGNOSTIC INSTRUMENTS) (January 28, 1981)
  • K803148 — CONPHAR PERCUSSION HAMMER(TAYLOR) (January 8, 1981)
  • K803174 — CONPHAR PERCUSSION HAMMER(BUCK TYPE) (December 30, 1980)
  • K791337 — TAYLOR NEUROLOGICAL HAMMER (August 3, 1979)

FDA data resources