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510(k) K851307

INOX DRY HEAT STERILIZER by Broadwest Corp. — Product Code KMH

K851307 is an FDA 510(k) premarket notification submitted by Broadwest Corp. for the device "INOX DRY HEAT STERILIZER". The FDA issued a decision of Substantially Equivalent on May 9, 1985. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Broadwest Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1985
Date Received
April 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Dry Heat
Device Class
Class II
Regulation Number
880.6870
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)
  • K852301 — INOX THERMOMETER JAR (July 1, 1985)
  • K852300 — INOX IV STAND (June 20, 1985)

Other clearances for product code KMH

  • K094026 — STERI-DENT, STERI-SURE (July 12, 2011)
  • K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (August 4, 2005)
  • K910925 — DISINFECTION WITH THE COX DRY HEAT STERILIZER (May 8, 1992)
  • K910202 — DENTRONIX MODEL 2000 (March 13, 1991)
  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (July 13, 1988)
  • K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (April 13, 1988)
  • K872643 — COX RAPID HEAT TRANSFER STERILIZER (October 29, 1987)
  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K771070 — DRY HEAT STERILIZER (July 14, 1977)

FDA data resources