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FDA 510(k)

TRANS-PACE 100

K-Number: K900220 · 1990-07-17

ApplicantSynchromed Corp.
Decision Date1990-07-17
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANS-PACE 100 is the device name listed in this FDA 510(k) record. The listed applicant is Synchromed Corp.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K900220. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS-PACE 100?

TRANS-PACE 100 is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Synchromed Corp.. The 510(k) number is K900220.

When did TRANS-PACE 100 receive FDA 510(k) clearance?

TRANS-PACE 100 received FDA 510(k) clearance on 1990-07-17, under 510(k) number K900220.

Who is the listed applicant for TRANS-PACE 100?

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

What is the FDA product code for TRANS-PACE 100?

The FDA product code for TRANS-PACE 100 is DTE.

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Related Devices (Code: DTE)

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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