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FDA 510(k)

PENTAX ST-1A

K-Number: K780738 · 1978-07-17

ApplicantHal-Hen Co., Inc.
Decision Date1978-07-17
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PENTAX ST-1A is the device name listed in this FDA 510(k) record. The listed applicant is Hal-Hen Co., Inc.. It received FDA 510(k) clearance on 1978-07-17 under 510(k) number K780738. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX ST-1A?

PENTAX ST-1A is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Hal-Hen Co., Inc.. The 510(k) number is K780738.

When did PENTAX ST-1A receive FDA 510(k) clearance?

PENTAX ST-1A received FDA 510(k) clearance on 1978-07-17, under 510(k) number K780738.

Who is the listed applicant for PENTAX ST-1A?

The FDA 510(k) record lists Hal-Hen Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX ST-1A?

The FDA product code for PENTAX ST-1A is DQD.

Related Clinical Trials

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Other records listing Hal-Hen Co., 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.

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Official Source

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