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510(k) K042889

DYNAMOMETER - MODEL FCE AND MODEL MSC by Ametek — Product Code LBB

K042889 is an FDA 510(k) premarket notification submitted by Ametek for the device "DYNAMOMETER - MODEL FCE AND MODEL MSC". The FDA issued a decision of Substantially Equivalent on November 16, 2004. The device falls under product code LBB (Dynamometer, Ac-Powered), a Class II device regulated under 21 CFR 888.1240. Ametek has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2004
Date Received
October 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dynamometer, Ac-Powered
Device Class
Class II
Regulation Number
888.1240
Review Panel
NE
Submission Type

Other clearances by Ametek

  • K943824 — GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION (November 1, 1996)
  • K942113 — CARBON DIOXIDE ANALYZER (MODEL CD-3A) (February 16, 1995)

Other clearances for product code LBB

  • K162412 — Hoggan Scientific® microFET2™ (March 9, 2017)
  • K073154 — FACTS HAND AND PINCH GRIP COMBO (February 14, 2008)
  • K052309 — DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 (September 27, 2005)
  • K012492 — KADANCE 2000 (November 2, 2001)
  • K981730 — DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (July 17, 1998)
  • K980363 — ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI) (April 16, 1998)
  • K964933 — MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) (February 3, 1997)
  • K964685 — DYNAMOMETER (January 27, 1997)
  • K935757 — GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM (April 15, 1994)
  • K931321 — CSD 200/300/400/500 DYNAMOMETER (February 15, 1994)

FDA data resources