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510(k) K811631

THERMOMETER (MADE IN CHINA) by Robert I. Chien & Assoc., Inc. — Product Code FLK

K811631 is an FDA 510(k) premarket notification submitted by Robert I. Chien & Assoc., Inc. for the device "THERMOMETER (MADE IN CHINA)". The FDA issued a decision of Substantially Equivalent on July 20, 1981. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Robert I. Chien & Assoc., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
June 9, 1981
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 Robert I. Chien & Assoc., Inc.

  • K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (August 19, 1982)
  • K811632 — UNSTERILIZED LAPAROTOMY SPONGES (CHINA) (September 11, 1981)
  • K810054 — RICA (DIAGNOSTIC INSTRUMENTS) (January 28, 1981)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

Other clearances for product code FLK

  • K960185 — AMSINO CLINICAL THERMOMETER (March 28, 1996)
  • K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (March 25, 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)

FDA data resources