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FDA 510(k)

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

K-Number: K011868 · 2001-09-04

ApplicantDebio Tech SA
Decision Date2001-09-04
Product CodeLZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS is the device name listed in this FDA 510(k) record. The listed applicant is Debio Tech SA. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K011868. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS?

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Debio Tech SA. The 510(k) number is K011868.

When did ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS receive FDA 510(k) clearance?

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS received FDA 510(k) clearance on 2001-09-04, under 510(k) number K011868.

Who is the listed applicant for ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS?

The FDA 510(k) record lists Debio Tech SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS?

The FDA product code for ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS is LZH.

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Related Devices (Code: LZH)

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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