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510(k) K811179

OSMOMETER MODEL OM-6010 by Fiske Med Science — Product Code JJM

K811179 is an FDA 510(k) premarket notification submitted by Fiske Med Science for the device "OSMOMETER MODEL OM-6010". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code JJM (Osmometer For Clinical Use), a Class I device regulated under 21 CFR 862.2730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osmometer For Clinical Use
Device Class
Class I
Regulation Number
862.2730
Review Panel
CH
Submission Type

Other clearances for product code JJM

  • K965036 — THE ADVANCED OSMOMETER (3900) (February 20, 1997)
  • K962056 — ADVANCED MICRO-OSMOMETER MODEL 3300 (July 11, 1996)
  • K925970 — MODEL 3D3 OSMOMETER (July 9, 1993)
  • K911092 — OSMOMETER MODEL 2400 (May 22, 1991)
  • K873642 — OSMOMETER MODEL 110 (October 20, 1987)
  • K843997 — AO-10 AUTOMATED OSMOMETER (October 31, 1984)
  • K842750 — OSMOTIC PRESSURE AUTO & STAT OM-6010 (August 17, 1984)
  • K834214 — WESCOR 5500 VAPOR PRESSURE OSMOMETER (March 30, 1984)
  • K834208 — COLLOID OSMOMETER 4400 (March 23, 1984)
  • K832783 — MICRO-SAMPLE OSMOMETER 3M0 (November 28, 1983)

FDA data resources