FDA 510(k)

SH-1

K-Number: K770344 · 1977-05-09

Decision Date1977-05-09

Product CodeCBN

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SH-1 is the device name listed in this FDA 510(k) record. The listed applicant is Delta Medical Industries. It received FDA 510(k) clearance on 1977-05-09 under 510(k) number K770344. The device is classified under product code CBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SH-1?

SH-1 is a medical device that received FDA 510(k) clearance on 1977-05-09. The listed applicant is Delta Medical Industries. The 510(k) number is K770344.

When did SH-1 receive FDA 510(k) clearance?

SH-1 received FDA 510(k) clearance on 1977-05-09, under 510(k) number K770344.

Who is the listed applicant for SH-1?

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

What is the FDA product code for SH-1?

The FDA product code for SH-1 is CBN.

Other records listing Delta Medical Industries 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.

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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.