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510(k) K981563

BIOPAK MEASUREMENT SYSTEM by Bio-Research Associates, Inc. — Product Code KZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1998
Date Received
May 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Muscle Monitoring
Device Class
Class II
Regulation Number
890.1375
Review Panel
DE
Submission Type

Other clearances by Bio-Research Associates, Inc.

  • K130158 — M-SCAN (July 25, 2013)
  • K082927 — BIOEMG III (February 6, 2009)
  • K061799 — QUADRATENS, MODEL QT-42 (August 28, 2006)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K991756 — 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE (December 10, 1999)
  • K952218 — JT-3 ELECTROGNATHOGRAPH (September 21, 1995)
  • K873947 — BIO-EMG MODEL 800 (April 27, 1988)
  • K844618 — BIO-TENS (August 21, 1985)
  • K822565 — NEEDLE CATHETER JEJUNOSTOMY KIT (September 28, 1982)

Other clearances for product code KZM

  • K161716 — TEETHAN 2.0 (December 21, 2016)
  • K130158 — M-SCAN (July 25, 2013)
  • K113677 — GRINDCARE MEASURE (April 5, 2012)
  • K082927 — BIOEMG III (February 6, 2009)
  • K043373 — DOLOTENS DENTAL TM 1 (September 2, 2005)
  • K030869 — BITESTRIP (May 14, 2004)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K003287 — MODEL K7 EVALUATION DEVICE (November 6, 2000)
  • K992694 — MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (September 10, 1999)
  • K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (December 9, 1994)