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FDA 510(k)

AMBULATORY MARK I

K-Number: K822842 · 1983-03-24

ApplicantWindsor Medical, Inc.
Decision Date1983-03-24
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMBULATORY MARK I is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Medical, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K822842. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY MARK I?

AMBULATORY MARK I is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Windsor Medical, Inc.. The 510(k) number is K822842.

When did AMBULATORY MARK I receive FDA 510(k) clearance?

AMBULATORY MARK I received FDA 510(k) clearance on 1983-03-24, under 510(k) number K822842.

Who is the listed applicant for AMBULATORY MARK I?

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

What is the FDA product code for AMBULATORY MARK I?

The FDA product code for AMBULATORY MARK I is FRN.

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Other records listing Windsor Medical, 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.

K841481WINDSOR MEDICAL MODEL 50-00002K832606WINDSOR MEDICAL VARIOUS MODELSK832641WINDSOR MEDICAL MODEL 52K830657AMBULATORY MARK XI DRUG INFUSION DEV-K830656AMBULATORY MARK III INFUSION DEVICEK830544WINDSOR MEDICAL, INC. 50-01-028

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Related Devices (Code: FRN)

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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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