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FDA 510(k)

INOX DRY HEAT STERILIZER

K-Number: K851307 · 1985-05-09

ApplicantBroadwest Corp.
Decision Date1985-05-09
Product CodeKMH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INOX DRY HEAT STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Broadwest Corp.. It received FDA 510(k) clearance on 1985-05-09 under 510(k) number K851307. The device is classified under product code KMH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOX DRY HEAT STERILIZER?

INOX DRY HEAT STERILIZER is a medical device that received FDA 510(k) clearance on 1985-05-09. The listed applicant is Broadwest Corp.. The 510(k) number is K851307.

When did INOX DRY HEAT STERILIZER receive FDA 510(k) clearance?

INOX DRY HEAT STERILIZER received FDA 510(k) clearance on 1985-05-09, under 510(k) number K851307.

Who is the listed applicant for INOX DRY HEAT STERILIZER?

The FDA 510(k) record lists Broadwest Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INOX DRY HEAT STERILIZER?

The FDA product code for INOX DRY HEAT STERILIZER is KMH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Broadwest Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K864499PODOSCOPEK864569PODODIGITALK852302INOX IORCEPS JARK852301INOX THERMOMETER JARK852300INOX IV STAND

Related Devices (Code: KMH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K094026STERI-DENT, STERI-SURECpac, Inc.K051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMColtene/Whaledent, Inc.K910925DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.K910202DENTRONIX MODEL 2000Dentronix, Inc.K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.K881371COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLECox Sterile Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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