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FDA 510(k)

SPIR-E-VAC

K-Number: K771241 · 1977-09-15

ApplicantBreathing Services, Inc.
Decision Date1977-09-15
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIR-E-VAC is the device name listed in this FDA 510(k) record. The listed applicant is Breathing Services, Inc.. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771241. The device is classified under product code CAN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIR-E-VAC?

SPIR-E-VAC is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Breathing Services, Inc.. The 510(k) number is K771241.

When did SPIR-E-VAC receive FDA 510(k) clearance?

SPIR-E-VAC received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771241.

Who is the listed applicant for SPIR-E-VAC?

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

What is the FDA product code for SPIR-E-VAC?

The FDA product code for SPIR-E-VAC is CAN.

Related Devices (Code: CAN)

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.

K162811MR Conditional CGA 870Essex Industries, Inc.K080243PORTABLE OXYGEN UNIT SCA900San Cheong Co. , Ltd.K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATORRemcore, Inc.K061785CYL-FIL OXYGEN SYSTEMResponsive Respiratory, Inc.K950777OXYGEN REGULATORMada Medical Products, Inc.K942751VANGUARD SERIES GAS REGULATORSBuckman Co., 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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