FDA 510(k)

S.P. 100

K-Number: K970696 · 1997-03-18

Decision Date1997-03-18

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

S.P. 100 is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Intl., Inc.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K970696. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S.P. 100?

S.P. 100 is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Lsi Intl., Inc.. The 510(k) number is K970696.

When did S.P. 100 receive FDA 510(k) clearance?

S.P. 100 received FDA 510(k) clearance on 1997-03-18, under 510(k) number K970696.

Who is the listed applicant for S.P. 100?

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

What is the FDA product code for S.P. 100?

The FDA product code for S.P. 100 is GZJ.

Other records listing Lsi Intl., 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.

K002390QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H K984021MS300 K984113MS400 K933653MS 2500

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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.