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FDA 510(k)

THE SPIRA ELEKTRO 2

K-Number: K871151 · 1987-05-15

ApplicantWarren E. Collins, Inc.
Decision Date1987-05-15
Product CodeCCQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE SPIRA ELEKTRO 2 is the device name listed in this FDA 510(k) record. The listed applicant is Warren E. Collins, Inc.. It received FDA 510(k) clearance on 1987-05-15 under 510(k) number K871151. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SPIRA ELEKTRO 2?

THE SPIRA ELEKTRO 2 is a medical device that received FDA 510(k) clearance on 1987-05-15. The listed applicant is Warren E. Collins, Inc.. The 510(k) number is K871151.

When did THE SPIRA ELEKTRO 2 receive FDA 510(k) clearance?

THE SPIRA ELEKTRO 2 received FDA 510(k) clearance on 1987-05-15, under 510(k) number K871151.

Who is the listed applicant for THE SPIRA ELEKTRO 2?

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

What is the FDA product code for THE SPIRA ELEKTRO 2?

The FDA product code for THE SPIRA ELEKTRO 2 is CCQ.

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Other records listing Warren E. Collins, 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.

K925459GS-MODULAR (GOLD STANDARD - MODULAR)K912946COLLINS DIGITAL PULMONARY MANOMETERK861227COLLINS PNEUMOTACH PFT SYSTEMK852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMK831780METABOLIC EXERCISE TESTING SYSTEMK831778RS-RESIDUAL VOLUME SYSTEM

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Related Devices (Code: CCQ)

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.

K972397EZ SPRAYIntertex Research, Inc.K964956E-Z SPACER MASK (SMALL)Airpharma, LLCK961894MDI TUTORMdi Tutor, Inc.K961455MEDSHIELD/AEROCHAMBERDiemolding Corp.K960593SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100Aradigm Corp.K922033SALINE SOLUTION- STERILETrinity Laboratories, 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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