FDA 510(k)

SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES

K-Number: K904017 · 1991-03-21

Decision Date1991-03-21

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Ultrasound, Inc.. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K904017. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES?

SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Siemens Ultrasound, Inc.. The 510(k) number is K904017.

When did SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES receive FDA 510(k) clearance?

SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES received FDA 510(k) clearance on 1991-03-21, under 510(k) number K904017.

Who is the listed applicant for SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES?

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

What is the FDA product code for SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES?

The FDA product code for SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES is IYN.

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Other records listing Siemens Ultrasound, Inc. as applicant

K914013SIEMENS SI-400 K912361SI-450/ILUS (INTRALUMINAL ULTRASOUND)K911200SI-1200 / ILUS K9106695 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU K9105297.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS K891449SONOLINE CF

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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.