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FDA 510(k)

CRYSTAL EAR

K-Number: K942189 · 1994-08-09

ApplicantCrystal Care Intl., Inc.
Decision Date1994-08-09
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CRYSTAL EAR is the device name listed in this FDA 510(k) record. The listed applicant is Crystal Care Intl., Inc.. It received FDA 510(k) clearance on 1994-08-09 under 510(k) number K942189. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYSTAL EAR?

CRYSTAL EAR is a medical device that received FDA 510(k) clearance on 1994-08-09. The listed applicant is Crystal Care Intl., Inc.. The 510(k) number is K942189.

When did CRYSTAL EAR receive FDA 510(k) clearance?

CRYSTAL EAR received FDA 510(k) clearance on 1994-08-09, under 510(k) number K942189.

Who is the listed applicant for CRYSTAL EAR?

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

What is the FDA product code for CRYSTAL EAR?

The FDA product code for CRYSTAL EAR is ESD.

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Related Devices (Code: ESD)

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

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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