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FDA 510(k)

AIC - CHEK (HBAIC-I)

K-Number: K973365 · 1998-06-15

ApplicantExpress-Med, Inc.
Decision Date1998-06-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AIC - CHEK (HBAIC-I) is the device name listed in this FDA 510(k) record. The listed applicant is Express-Med, Inc.. It received FDA 510(k) clearance on 1998-06-15 under 510(k) number K973365. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIC - CHEK (HBAIC-I)?

AIC - CHEK (HBAIC-I) is a medical device that received FDA 510(k) clearance on 1998-06-15. The listed applicant is Express-Med, Inc.. The 510(k) number is K973365.

When did AIC - CHEK (HBAIC-I) receive FDA 510(k) clearance?

AIC - CHEK (HBAIC-I) received FDA 510(k) clearance on 1998-06-15, under 510(k) number K973365.

Who is the listed applicant for AIC - CHEK (HBAIC-I)?

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

What is the FDA product code for AIC - CHEK (HBAIC-I)?

The FDA product code for AIC - CHEK (HBAIC-I) is LCP.

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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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