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FDA 510(k)

EXAMINER 10

K-Number: K781698 · 1978-11-03

ApplicantAmerican Sterilizer Co.
Decision Date1978-11-03
Product CodeHJE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXAMINER 10 is the device name listed in this FDA 510(k) record. The listed applicant is American Sterilizer Co.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781698. The device is classified under product code HJE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXAMINER 10?

EXAMINER 10 is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is American Sterilizer Co.. The 510(k) number is K781698.

When did EXAMINER 10 receive FDA 510(k) clearance?

EXAMINER 10 received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781698.

Who is the listed applicant for EXAMINER 10?

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

What is the FDA product code for EXAMINER 10?

The FDA product code for EXAMINER 10 is HJE.

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Other records listing American Sterilizer Co. 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.

K943288AMSCO SQ240 SURGICAL LIGHTK931872THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERK922485CHEMDI-VHP CHEMICAL INDICATORK930493QUANTUM 3080 SURGICAL TABLEK905816ORTHOVISION TABLEK896674AMSCO QUANTUM LIGHT

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Related Devices (Code: HJE)

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.

K922348VALTRAC(R) INTRODUCER FORCEPAmerican Cyanamid Co.K802291FLUORESCENT SUN LAMP FIXTUREStrato-Ray Co.

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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