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FDA 510(k)

MODIFIED RADIUS - MODEL NUMBER MM 5000

K-Number: K871727 · 1987-09-30

ApplicantUltrasonix, Inc.
Decision Date1987-09-30
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED RADIUS - MODEL NUMBER MM 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasonix, Inc.. It received FDA 510(k) clearance on 1987-09-30 under 510(k) number K871727. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED RADIUS - MODEL NUMBER MM 5000?

MODIFIED RADIUS - MODEL NUMBER MM 5000 is a medical device that received FDA 510(k) clearance on 1987-09-30. The listed applicant is Ultrasonix, Inc.. The 510(k) number is K871727.

When did MODIFIED RADIUS - MODEL NUMBER MM 5000 receive FDA 510(k) clearance?

MODIFIED RADIUS - MODEL NUMBER MM 5000 received FDA 510(k) clearance on 1987-09-30, under 510(k) number K871727.

Who is the listed applicant for MODIFIED RADIUS - MODEL NUMBER MM 5000?

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

What is the FDA product code for MODIFIED RADIUS - MODEL NUMBER MM 5000?

The FDA product code for MODIFIED RADIUS - MODEL NUMBER MM 5000 is JOP.

Related Clinical Trials

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Other records listing Ultrasonix, 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.

K851901750 SD ULTRASOUND SCANNER(MODIFICATION)

Related Devices (Code: JOP)

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.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLCK153762Smartdop XT6Koven Technology, Inc.K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLCK111416FALCONViasonix , Ltd.K071730STUDIODOP VICORDERSkidmore Medical, Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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