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FDA 510(k)

ALICE 4R SYSTEM

K-Number: K971867 · 1997-08-13

ApplicantHealthdyne Technologies, Inc.
Decision Date1997-08-13
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALICE 4R SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Technologies, Inc.. It received FDA 510(k) clearance on 1997-08-13 under 510(k) number K971867. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALICE 4R SYSTEM?

ALICE 4R SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-13. The listed applicant is Healthdyne Technologies, Inc.. The 510(k) number is K971867.

When did ALICE 4R SYSTEM receive FDA 510(k) clearance?

ALICE 4R SYSTEM received FDA 510(k) clearance on 1997-08-13, under 510(k) number K971867.

Who is the listed applicant for ALICE 4R SYSTEM?

The FDA 510(k) record lists Healthdyne Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALICE 4R SYSTEM?

The FDA product code for ALICE 4R SYSTEM is OLV.

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Other records listing Healthdyne Technologies, Inc. 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.

K983572SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500K974453NASAL INTERFACE MODEL 7910K974879MODEL 7410 VOYAGERK972614TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605K971545PROTEGE LIQUID OXYGEN SYSTEMK970173MODEL 1700 TRANQUILITY BILEVEL SYSTEM

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Related Devices (Code: OLV)

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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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