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FDA 510(k)

PY30, PY60, PY80

K-Number: K944928 · 1995-01-27

ApplicantHuttinger Medizintechnik GmbH & CO KG
Decision Date1995-01-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PY30, PY60, PY80 is the device name listed in this FDA 510(k) record. The listed applicant is Huttinger Medizintechnik GmbH & CO KG. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K944928. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PY30, PY60, PY80?

PY30, PY60, PY80 is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Huttinger Medizintechnik GmbH & CO KG. The 510(k) number is K944928.

When did PY30, PY60, PY80 receive FDA 510(k) clearance?

PY30, PY60, PY80 received FDA 510(k) clearance on 1995-01-27, under 510(k) number K944928.

Who is the listed applicant for PY30, PY60, PY80?

The FDA 510(k) record lists Huttinger Medizintechnik GmbH & CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PY30, PY60, PY80?

The FDA product code for PY30, PY60, PY80 is GEX. This falls under the Gastroenterology category.

Other records listing Huttinger Medizintechnik GmbH & CO KG as applicant

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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