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FDA 510(k)

ACCUTHERM PTS-200

K-Number: K890575 · 1989-05-05

ApplicantMedical Repackers Co.
Decision Date1989-05-05
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUTHERM PTS-200 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Repackers Co.. It received FDA 510(k) clearance on 1989-05-05 under 510(k) number K890575. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTHERM PTS-200?

ACCUTHERM PTS-200 is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Medical Repackers Co.. The 510(k) number is K890575.

When did ACCUTHERM PTS-200 receive FDA 510(k) clearance?

ACCUTHERM PTS-200 received FDA 510(k) clearance on 1989-05-05, under 510(k) number K890575.

Who is the listed applicant for ACCUTHERM PTS-200?

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

What is the FDA product code for ACCUTHERM PTS-200?

The FDA product code for ACCUTHERM PTS-200 is DWJ.

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Other records listing Medical Repackers Co. 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.

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Related Devices (Code: DWJ)

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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