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FDA 510(k)

I-SURGE

K-Number: K071965 · 2007-09-10

ApplicantSatelec
Decision Date2007-09-10
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-SURGE is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2007-09-10 under 510(k) number K071965. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-SURGE?

I-SURGE is a medical device that received FDA 510(k) clearance on 2007-09-10. The listed applicant is Satelec. The 510(k) number is K071965.

When did I-SURGE receive FDA 510(k) clearance?

I-SURGE received FDA 510(k) clearance on 2007-09-10, under 510(k) number K071965.

Who is the listed applicant for I-SURGE?

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

What is the FDA product code for I-SURGE?

The FDA product code for I-SURGE is EFB.

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Related Devices (Code: EFB)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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