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FDA 510(k)

OTOSCREENER-I AND OTO-SCREEN-I-P

K-Number: K903143 · 1990-09-19

ApplicantHandtronix, Inc.
Decision Date1990-09-19
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOSCREENER-I AND OTO-SCREEN-I-P is the device name listed in this FDA 510(k) record. The listed applicant is Handtronix, Inc.. It received FDA 510(k) clearance on 1990-09-19 under 510(k) number K903143. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOSCREENER-I AND OTO-SCREEN-I-P?

OTOSCREENER-I AND OTO-SCREEN-I-P is a medical device that received FDA 510(k) clearance on 1990-09-19. The listed applicant is Handtronix, Inc.. The 510(k) number is K903143.

When did OTOSCREENER-I AND OTO-SCREEN-I-P receive FDA 510(k) clearance?

OTOSCREENER-I AND OTO-SCREEN-I-P received FDA 510(k) clearance on 1990-09-19, under 510(k) number K903143.

Who is the listed applicant for OTOSCREENER-I AND OTO-SCREEN-I-P?

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

What is the FDA product code for OTOSCREENER-I AND OTO-SCREEN-I-P?

The FDA product code for OTOSCREENER-I AND OTO-SCREEN-I-P is EWO.

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Related Devices (Code: EWO)

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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Official Source

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

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