FDA 510(k)

RECORDING UNIT, MODEL 1445

K-Number: K770829 · 1977-05-18

Decision Date1977-05-18

Product Code

DecisionSubstantially Equivalent

Device Summary

RECORDING UNIT, MODEL 1445 is the device name listed in this FDA 510(k) record. The listed applicant is Scole Engineering Co.. It received FDA 510(k) clearance on 1977-05-18 under 510(k) number K770829. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECORDING UNIT, MODEL 1445?

RECORDING UNIT, MODEL 1445 is a medical device that received FDA 510(k) clearance on 1977-05-18. The listed applicant is Scole Engineering Co.. The 510(k) number is K770829.

When did RECORDING UNIT, MODEL 1445 receive FDA 510(k) clearance?

RECORDING UNIT, MODEL 1445 received FDA 510(k) clearance on 1977-05-18, under 510(k) number K770829.

Who is the listed applicant for RECORDING UNIT, MODEL 1445?

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

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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.