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510(k) K960224

GERATHERM MERCUIRY FREE CLINICAL THERMOMETER by Rg Ent., Inc. — Product Code FLK

K960224 is an FDA 510(k) premarket notification submitted by Rg Ent., Inc. for the device "GERATHERM MERCUIRY FREE CLINICAL THERMOMETER". The FDA issued a decision of Substantially Equivalent on March 25, 1996. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Rg Ent., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1996
Date Received
January 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Mercury
Device Class
Class II
Regulation Number
880.2920
Review Panel
HO
Submission Type

Other clearances by Rg Ent., Inc.

  • K051278 — GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) (June 29, 2006)
  • K051097 — GERATHERM SOS-RESCUE BLANKET (February 24, 2006)

Other clearances for product code FLK

  • K960185 — AMSINO CLINICAL THERMOMETER (March 28, 1996)
  • K953465 — KENTEMP (December 15, 1995)
  • K942483 — CLINICAL GLASS THERMOMETER (March 28, 1995)
  • K941673 — MEDIAID UNIVERSAL THERMOMETER (August 25, 1994)
  • K940394 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K940380 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K932991 — GUARDIAN AND ANDINO MODELS (January 28, 1994)
  • K923225 — LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME (June 8, 1993)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)

FDA data resources