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FDA 510(k)

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

K-Number: K964978 · 1997-05-21

ApplicantQuinton, Inc.
Decision Date1997-05-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K964978. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)?

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Quinton, Inc.. The 510(k) number is K964978.

When did VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) receive FDA 510(k) clearance?

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) received FDA 510(k) clearance on 1997-05-21, under 510(k) number K964978.

Who is the listed applicant for VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)?

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 VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)?

The FDA product code for VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) is DQA.

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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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Related Devices (Code: DQA)

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.

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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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