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FDA 510(k)

SONOLINE SL-2(ULTRASOUND SCANNER)

K-Number: K853008 · 1986-01-13

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1986-01-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOLINE SL-2(ULTRASOUND SCANNER) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K853008. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOLINE SL-2(ULTRASOUND SCANNER)?

SONOLINE SL-2(ULTRASOUND SCANNER) is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K853008.

When did SONOLINE SL-2(ULTRASOUND SCANNER) receive FDA 510(k) clearance?

SONOLINE SL-2(ULTRASOUND SCANNER) received FDA 510(k) clearance on 1986-01-13, under 510(k) number K853008.

Who is the listed applicant for SONOLINE SL-2(ULTRASOUND SCANNER)?

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

What is the FDA product code for SONOLINE SL-2(ULTRASOUND SCANNER)?

The FDA product code for SONOLINE SL-2(ULTRASOUND SCANNER) is IYO.

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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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