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FDA 510(k)

SPIRO-FLEX

K-Number: K945565 · 1995-01-13

ApplicantInhalation Plastics
Decision Date1995-01-13
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRO-FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Inhalation Plastics. It received FDA 510(k) clearance on 1995-01-13 under 510(k) number K945565. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRO-FLEX?

SPIRO-FLEX is a medical device that received FDA 510(k) clearance on 1995-01-13. The listed applicant is Inhalation Plastics. The 510(k) number is K945565.

When did SPIRO-FLEX receive FDA 510(k) clearance?

SPIRO-FLEX received FDA 510(k) clearance on 1995-01-13, under 510(k) number K945565.

Who is the listed applicant for SPIRO-FLEX?

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

What is the FDA product code for SPIRO-FLEX?

The FDA product code for SPIRO-FLEX is CAI.

Related Clinical Trials

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Other records listing Inhalation Plastics 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.

K914686THERMO-FLOW SETK901315AEROMIST II NEBULIZERK900990FILT-R-ALL BACTERIAL/VIRAL FILTERK900594ANESTHESIA BREATHING CIRCUITK896832FILT-R-ALL BACTERIAL FILTERK874659STERILIZATION OF DEVICES BY RADIATION

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Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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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