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510(k) K852301

INOX THERMOMETER JAR by Broadwest Corp. — Product Code FLK

K852301 is an FDA 510(k) premarket notification submitted by Broadwest Corp. for the device "INOX THERMOMETER JAR". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Broadwest Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1985
Date Received
May 29, 1985
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 Broadwest Corp.

  • K864499 — PODOSCOPE (February 4, 1987)
  • K864569 — PODODIGITAL (February 4, 1987)
  • K852302 — INOX IORCEPS JAR (July 2, 1985)
  • K852300 — INOX IV STAND (June 20, 1985)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)

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