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FDA 510(k)

DISPETTE II

K-Number: K860899 · 1986-04-14

Decision Date1986-04-14
Product CodeJPH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DISPETTE II is the device name listed in this FDA 510(k) record. The listed applicant is Ulster Scientific, Inc.. It received FDA 510(k) clearance on 1986-04-14 under 510(k) number K860899. The device is classified under product code JPH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPETTE II?

DISPETTE II is a medical device that received FDA 510(k) clearance on 1986-04-14. The listed applicant is Ulster Scientific, Inc.. The 510(k) number is K860899.

When did DISPETTE II receive FDA 510(k) clearance?

DISPETTE II received FDA 510(k) clearance on 1986-04-14, under 510(k) number K860899.

Who is the listed applicant for DISPETTE II?

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

What is the FDA product code for DISPETTE II?

The FDA product code for DISPETTE II is JPH.

Related Clinical Trials

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.

Other records listing Ulster Scientific, 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.

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Related Devices (Code: JPH)

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.

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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