Home / 510(k) Clearances / K873947

510(k) K873947

BIO-EMG MODEL 800 by Bio-Research Associates, Inc. — Product Code KZM

K873947 is an FDA 510(k) premarket notification submitted by Bio-Research Associates, Inc. for the device "BIO-EMG MODEL 800". The FDA issued a decision of Substantially Equivalent on April 27, 1988. 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
April 27, 1988
Date Received
September 28, 1987
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)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • K952218 — JT-3 ELECTROGNATHOGRAPH (September 21, 1995)
  • 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)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)

FDA data resources