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FDA 510(k)

HYPER-K HEAT SYSTEM

K-Number: K912722 · 1991-09-11

ApplicantBaxter Healthcare Corp
Decision Date1991-09-11
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HYPER-K HEAT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-09-11 under 510(k) number K912722. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPER-K HEAT SYSTEM?

HYPER-K HEAT SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K912722.

When did HYPER-K HEAT SYSTEM receive FDA 510(k) clearance?

HYPER-K HEAT SYSTEM received FDA 510(k) clearance on 1991-09-11, under 510(k) number K912722.

Who is the listed applicant for HYPER-K HEAT SYSTEM?

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

What is the FDA product code for HYPER-K HEAT SYSTEM?

The FDA product code for HYPER-K HEAT SYSTEM is ILO.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: ILO)

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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