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FDA 510(k)

ULTRAMAX/MODEL NUMBER A1

K-Number: K960044 · 1996-08-02

ApplicantEntlab OY
Decision Date1996-08-02
Product CodeLWI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAMAX/MODEL NUMBER A1 is the device name listed in this FDA 510(k) record. The listed applicant is Entlab OY. It received FDA 510(k) clearance on 1996-08-02 under 510(k) number K960044. The device is classified under product code LWI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAMAX/MODEL NUMBER A1?

ULTRAMAX/MODEL NUMBER A1 is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is Entlab OY. The 510(k) number is K960044.

When did ULTRAMAX/MODEL NUMBER A1 receive FDA 510(k) clearance?

ULTRAMAX/MODEL NUMBER A1 received FDA 510(k) clearance on 1996-08-02, under 510(k) number K960044.

Who is the listed applicant for ULTRAMAX/MODEL NUMBER A1?

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

What is the FDA product code for ULTRAMAX/MODEL NUMBER A1?

The FDA product code for ULTRAMAX/MODEL NUMBER A1 is LWI.

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Related Devices (Code: LWI)

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.

K960421SINUSCAN 102/SINUSPRINTFerguson MedicalK960241CPR GENERAL SURGERY TRAYCustom Pack ReliabilityK874081ENTERSCANPie Data Medical BV

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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