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FDA 510(k)

RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)

K-Number: K925929 · 1993-03-15

ApplicantRstar, Inc.
Decision Date1993-03-15
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS) is the device name listed in this FDA 510(k) record. The listed applicant is Rstar, Inc.. It received FDA 510(k) clearance on 1993-03-15 under 510(k) number K925929. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)?

RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS) is a medical device that received FDA 510(k) clearance on 1993-03-15. The listed applicant is Rstar, Inc.. The 510(k) number is K925929.

When did RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS) receive FDA 510(k) clearance?

RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS) received FDA 510(k) clearance on 1993-03-15, under 510(k) number K925929.

Who is the listed applicant for RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)?

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

What is the FDA product code for RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)?

The FDA product code for RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS) is LMD.

Related Clinical Trials

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Other records listing Rstar, 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.

K925994RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)

Related Devices (Code: LMD)

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

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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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