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FDA 510(k)

SFD-035 SPOT FILM DEVICE

K-Number: K902146 · 1990-05-31

ApplicantRms Div.
Decision Date1990-05-31
Product CodeIXL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SFD-035 SPOT FILM DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Rms Div.. It received FDA 510(k) clearance on 1990-05-31 under 510(k) number K902146. The device is classified under product code IXL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SFD-035 SPOT FILM DEVICE?

SFD-035 SPOT FILM DEVICE is a medical device that received FDA 510(k) clearance on 1990-05-31. The listed applicant is Rms Div.. The 510(k) number is K902146.

When did SFD-035 SPOT FILM DEVICE receive FDA 510(k) clearance?

SFD-035 SPOT FILM DEVICE received FDA 510(k) clearance on 1990-05-31, under 510(k) number K902146.

Who is the listed applicant for SFD-035 SPOT FILM DEVICE?

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

What is the FDA product code for SFD-035 SPOT FILM DEVICE?

The FDA product code for SFD-035 SPOT FILM DEVICE is IXL.

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Other records listing Rms Div. 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.

K963367RMS K-WIREK954438SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPEK944848THE VIVACARE T.P.S. PROBEK944557DW250 #91K941625DW234 #29K902403ELITE R/F SPOT FILM DRIVE

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Related Devices (Code: IXL)

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.

K111304OPTIMA XR120Ge Medical Systems, LLCK964806MD-1835Fischer Imaging Corp.K950317ADVANTX 1824 SPOTFILM DEVICEGE Medical SystemsK940386KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LPEastman Kodak CompanyK942367AXT 1400 SPOTFILM DEVICEApplied X-Ray Technologies, Inc.K924593DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4Philips Medical Systems, 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.

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