Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOLA 700,SOLA 500, SOLA 300

K-Number: K010724 · 2001-06-07

ApplicantDrager Medizintechnik GmbH
Decision Date2001-06-07
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOLA 700,SOLA 500, SOLA 300 is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medizintechnik GmbH. It received FDA 510(k) clearance on 2001-06-07 under 510(k) number K010724. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLA 700,SOLA 500, SOLA 300?

SOLA 700,SOLA 500, SOLA 300 is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Drager Medizintechnik GmbH. The 510(k) number is K010724.

When did SOLA 700,SOLA 500, SOLA 300 receive FDA 510(k) clearance?

SOLA 700,SOLA 500, SOLA 300 received FDA 510(k) clearance on 2001-06-07, under 510(k) number K010724.

Who is the listed applicant for SOLA 700,SOLA 500, SOLA 300?

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

What is the FDA product code for SOLA 700,SOLA 500, SOLA 300?

The FDA product code for SOLA 700,SOLA 500, SOLA 300 is FTD.

Other records listing Drager Medizintechnik GmbH 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.

K023289OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072K010793OXYLOG 1000, MODEL 2M86840K012177VENTVIEW, MODEL 8414095K003068SAVINAK010093NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474K003067CALEO

View all 8 devices →

Related Devices (Code: FTD)

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.

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLCK130513VOLISTA 400; VOLISTA 600Maquet S.A.S.K123776POLARIS 100/200Drager Medical GmbHK111020ATRICURE DISSECTORAtriCure, Inc.K100234HM-LAMP IIHillusa, Inc.K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.

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.

↑