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FDA 510(k)

ELPER(TM) BARRIER INTEGRITY MONITORING

K-Number: K931153 · 1993-11-18

ApplicantIgea, S.R.L.
Decision Date1993-11-18
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELPER(TM) BARRIER INTEGRITY MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Igea, S.R.L.. It received FDA 510(k) clearance on 1993-11-18 under 510(k) number K931153. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPER(TM) BARRIER INTEGRITY MONITORING?

ELPER(TM) BARRIER INTEGRITY MONITORING is a medical device that received FDA 510(k) clearance on 1993-11-18. The listed applicant is Igea, S.R.L.. The 510(k) number is K931153.

When did ELPER(TM) BARRIER INTEGRITY MONITORING receive FDA 510(k) clearance?

ELPER(TM) BARRIER INTEGRITY MONITORING received FDA 510(k) clearance on 1993-11-18, under 510(k) number K931153.

Who is the listed applicant for ELPER(TM) BARRIER INTEGRITY MONITORING?

The FDA 510(k) record lists Igea, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELPER(TM) BARRIER INTEGRITY MONITORING?

The FDA product code for ELPER(TM) BARRIER INTEGRITY MONITORING is LDQ.

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Related Devices (Code: LDQ)

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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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