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FDA 510(k)

RMI RESPIRATORY GATING SYSTEM MODEL 301

K-Number: K854976 · 1986-05-07

ApplicantRadiation Measurements, Inc.
Decision Date1986-05-07
Product CodeIXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RMI RESPIRATORY GATING SYSTEM MODEL 301 is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Measurements, Inc.. It received FDA 510(k) clearance on 1986-05-07 under 510(k) number K854976. The device is classified under product code IXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMI RESPIRATORY GATING SYSTEM MODEL 301?

RMI RESPIRATORY GATING SYSTEM MODEL 301 is a medical device that received FDA 510(k) clearance on 1986-05-07. The listed applicant is Radiation Measurements, Inc.. The 510(k) number is K854976.

When did RMI RESPIRATORY GATING SYSTEM MODEL 301 receive FDA 510(k) clearance?

RMI RESPIRATORY GATING SYSTEM MODEL 301 received FDA 510(k) clearance on 1986-05-07, under 510(k) number K854976.

Who is the listed applicant for RMI RESPIRATORY GATING SYSTEM MODEL 301?

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

What is the FDA product code for RMI RESPIRATORY GATING SYSTEM MODEL 301?

The FDA product code for RMI RESPIRATORY GATING SYSTEM MODEL 301 is IXO.

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Other records listing Radiation Measurements, Inc. 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.

K893216RMI ULTRASOUND DOPPLER PHANTOM SYSTEMK885223RMI SHORT DISTANCE ALIGNMENT DEVICEK873956ULTIMETERK873836MAMMOGRAPHIC KVP METER MODEL 232K834483DIGI-XK834607ELECTRONIC KVP CASSETTE

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Related Devices (Code: IXO)

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.

K811587SIEMENS ANGIOTRONSiemens Corp.K810588SYNCHRONIZER #208Brattle Instrument Corp.K791959POST EXTRA SYSTOLIC POSTENTLATORMedrad, 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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