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FDA 510(k)

OPTI 110/12/50 HSG

K-Number: K781540 · 1978-09-14

ApplicantSiemens Corp.
Decision Date1978-09-14
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTI 110/12/50 HSG is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 1978-09-14 under 510(k) number K781540. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI 110/12/50 HSG?

OPTI 110/12/50 HSG is a medical device that received FDA 510(k) clearance on 1978-09-14. The listed applicant is Siemens Corp.. The 510(k) number is K781540.

When did OPTI 110/12/50 HSG receive FDA 510(k) clearance?

OPTI 110/12/50 HSG received FDA 510(k) clearance on 1978-09-14, under 510(k) number K781540.

Who is the listed applicant for OPTI 110/12/50 HSG?

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

What is the FDA product code for OPTI 110/12/50 HSG?

The FDA product code for OPTI 110/12/50 HSG is ITY.

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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.

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