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510(k) K130158

M-SCAN by Bio-Research Associates, Inc. — Product Code KZM

K130158 is an FDA 510(k) premarket notification submitted by Bio-Research Associates, Inc. for the device "M-SCAN". The FDA issued a decision of Substantially Equivalent on July 25, 2013. The device falls under product code KZM (Device, Muscle Monitoring), a Class II device regulated under 21 CFR 890.1375. Bio-Research Associates, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2013
Date Received
January 23, 2013
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.

  • 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)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • 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)
  • 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)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • K944134 — K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (December 9, 1994)

FDA data resources