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)

RT3600(115V) RT3600(220/240V)

K-Number: K853249 · 1985-12-09

ApplicantGeneral Electric Co.
Decision Date1985-12-09
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RT3600(115V) RT3600(220/240V) is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K853249. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RT3600(115V) RT3600(220/240V)?

RT3600(115V) RT3600(220/240V) is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is General Electric Co.. The 510(k) number is K853249.

When did RT3600(115V) RT3600(220/240V) receive FDA 510(k) clearance?

RT3600(115V) RT3600(220/240V) received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853249.

Who is the listed applicant for RT3600(115V) RT3600(220/240V)?

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

What is the FDA product code for RT3600(115V) RT3600(220/240V)?

The FDA product code for RT3600(115V) RT3600(220/240V) is ITX.

Other records listing General Electric Co. 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.

K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

View all 254 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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.

↑