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FDA 510(k)

S-SCORT (2500)

K-Number: K964997 · 1997-03-05

ApplicantSscor
Decision Date1997-03-05
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S-SCORT (2500) is the device name listed in this FDA 510(k) record. The listed applicant is Sscor. It received FDA 510(k) clearance on 1997-03-05 under 510(k) number K964997. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-SCORT (2500)?

S-SCORT (2500) is a medical device that received FDA 510(k) clearance on 1997-03-05. The listed applicant is Sscor. The 510(k) number is K964997.

When did S-SCORT (2500) receive FDA 510(k) clearance?

S-SCORT (2500) received FDA 510(k) clearance on 1997-03-05, under 510(k) number K964997.

Who is the listed applicant for S-SCORT (2500)?

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

What is the FDA product code for S-SCORT (2500)?

The FDA product code for S-SCORT (2500) is BTA.

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 Sscor 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.

Related Devices (Code: BTA)

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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