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FDA 510(k)

NEO-PNEUMOCATH

K-Number: K955474 · 1996-02-13

ApplicantIntra Special Catheters GmbH
Decision Date1996-02-13
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEO-PNEUMOCATH is the device name listed in this FDA 510(k) record. The listed applicant is Intra Special Catheters GmbH. It received FDA 510(k) clearance on 1996-02-13 under 510(k) number K955474. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-PNEUMOCATH?

NEO-PNEUMOCATH is a medical device that received FDA 510(k) clearance on 1996-02-13. The listed applicant is Intra Special Catheters GmbH. The 510(k) number is K955474.

When did NEO-PNEUMOCATH receive FDA 510(k) clearance?

NEO-PNEUMOCATH received FDA 510(k) clearance on 1996-02-13, under 510(k) number K955474.

Who is the listed applicant for NEO-PNEUMOCATH?

The FDA 510(k) record lists Intra Special Catheters GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO-PNEUMOCATH?

The FDA product code for NEO-PNEUMOCATH is GBX.

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Related Devices (Code: GBX)

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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