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FDA 510(k)

ISOLATE

K-Number: K971809 · 1997-07-03

ApplicantIrvine Scientific Sales Co., Inc.
Decision Date1997-07-03
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ISOLATE is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971809. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATE?

ISOLATE is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K971809.

When did ISOLATE receive FDA 510(k) clearance?

ISOLATE received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971809.

Who is the listed applicant for ISOLATE?

The FDA 510(k) record lists Irvine Scientific Sales Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLATE?

The FDA product code for ISOLATE is MQL.

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Related Devices (Code: MQL)

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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