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FDA 510(k)

PED ALERT

K-Number: K950656 · 1995-10-25

ApplicantOrbitec Technologies Corp.
Decision Date1995-10-25
Product CodeIRN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PED ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Orbitec Technologies Corp.. It received FDA 510(k) clearance on 1995-10-25 under 510(k) number K950656. The device is classified under product code IRN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PED ALERT?

PED ALERT is a medical device that received FDA 510(k) clearance on 1995-10-25. The listed applicant is Orbitec Technologies Corp.. The 510(k) number is K950656.

When did PED ALERT receive FDA 510(k) clearance?

PED ALERT received FDA 510(k) clearance on 1995-10-25, under 510(k) number K950656.

Who is the listed applicant for PED ALERT?

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

What is the FDA product code for PED ALERT?

The FDA product code for PED ALERT is IRN.

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Related Devices (Code: IRN)

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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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