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FDA 510(k)

Q101 DIAGNOSTIC SPIROMETER

K-Number: K863300 · 1986-11-13

ApplicantQuinton, Inc.
Decision Date1986-11-13
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Q101 DIAGNOSTIC SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K863300. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q101 DIAGNOSTIC SPIROMETER?

Q101 DIAGNOSTIC SPIROMETER is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Quinton, Inc.. The 510(k) number is K863300.

When did Q101 DIAGNOSTIC SPIROMETER receive FDA 510(k) clearance?

Q101 DIAGNOSTIC SPIROMETER received FDA 510(k) clearance on 1986-11-13, under 510(k) number K863300.

Who is the listed applicant for Q101 DIAGNOSTIC SPIROMETER?

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 Q101 DIAGNOSTIC SPIROMETER?

The FDA product code for Q101 DIAGNOSTIC SPIROMETER is BYT.

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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: BYT)

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.

K082657RTX RESPIRATORMedivent LimitedK072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.

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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