FDA 510(k)

AT64 SCR

K-Number: K930577 · 1995-05-18

Decision Date1995-05-18

Product CodeHCC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AT64 SCR is the device name listed in this FDA 510(k) record. The listed applicant is Autoject Systems, Inc.. It received FDA 510(k) clearance on 1995-05-18 under 510(k) number K930577. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AT64 SCR?

AT64 SCR is a medical device that received FDA 510(k) clearance on 1995-05-18. The listed applicant is Autoject Systems, Inc.. The 510(k) number is K930577.

When did AT64 SCR receive FDA 510(k) clearance?

AT64 SCR received FDA 510(k) clearance on 1995-05-18, under 510(k) number K930577.

Who is the listed applicant for AT64 SCR?

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

What is the FDA product code for AT64 SCR?

The FDA product code for AT64 SCR is HCC.

Other records listing Autoject Systems, 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.

K930578AT33 EMG K930576AT42 K853031JECT-AID

Related Devices (Code: HCC)

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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.