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FDA 510(k)

HYFRECATOR 2000

K-Number: K970493 · 1997-04-30

ApplicantAspen Labs
Decision Date1997-04-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYFRECATOR 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Labs. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K970493. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYFRECATOR 2000?

HYFRECATOR 2000 is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is Aspen Labs. The 510(k) number is K970493.

When did HYFRECATOR 2000 receive FDA 510(k) clearance?

HYFRECATOR 2000 received FDA 510(k) clearance on 1997-04-30, under 510(k) number K970493.

Who is the listed applicant for HYFRECATOR 2000?

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

What is the FDA product code for HYFRECATOR 2000?

The FDA product code for HYFRECATOR 2000 is GEI.

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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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