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FDA 510(k)

Q-SCAN II AND Q-SCAN III

K-Number: K864149 · 1986-12-10

ApplicantQuinton, Inc.
Decision Date1986-12-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q-SCAN II AND Q-SCAN III is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1986-12-10 under 510(k) number K864149. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-SCAN II AND Q-SCAN III?

Q-SCAN II AND Q-SCAN III is a medical device that received FDA 510(k) clearance on 1986-12-10. The listed applicant is Quinton, Inc.. The 510(k) number is K864149.

When did Q-SCAN II AND Q-SCAN III receive FDA 510(k) clearance?

Q-SCAN II AND Q-SCAN III received FDA 510(k) clearance on 1986-12-10, under 510(k) number K864149.

Who is the listed applicant for Q-SCAN II AND Q-SCAN III?

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

What is the FDA product code for Q-SCAN II AND Q-SCAN III?

The FDA product code for Q-SCAN II AND Q-SCAN III is DSI.

Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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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