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510(k) K870285

THERMOMETER SHEATHES, STERILE (GLASS) by The Medical Group, Inc. — Product Code FLK

K870285 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "THERMOMETER SHEATHES, STERILE (GLASS)". The FDA issued a decision of Substantially Equivalent on February 12, 1987. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1987
Date Received
January 27, 1987
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 The Medical Group, Inc.

  • K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (June 6, 1991)
  • K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (March 30, 1990)
  • K881843 — PEDIATRIC HOSPITAL BED (October 26, 1988)
  • K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM (July 14, 1988)
  • K870283 — 3 X 3 SPONGES, NON-STERILE (February 24, 1987)
  • K870282 — 4 X 4 SPONGES, NON-STERILE (February 24, 1987)
  • K870284 — TRIANGULAR BANDAGE (February 24, 1987)
  • K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (October 30, 1986)
  • K863769 — EVACUATOR TIPS (October 30, 1986)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)

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