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FDA 510(k)

SPIROCAL

K-Number: K791294 · 1979-08-16

ApplicantEquilibrated Bio Systems, Inc.
Decision Date1979-08-16
Product CodeBXX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROCAL is the device name listed in this FDA 510(k) record. The listed applicant is Equilibrated Bio Systems, Inc.. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K791294. The device is classified under product code BXX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROCAL?

SPIROCAL is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Equilibrated Bio Systems, Inc.. The 510(k) number is K791294.

When did SPIROCAL receive FDA 510(k) clearance?

SPIROCAL received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791294.

Who is the listed applicant for SPIROCAL?

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

What is the FDA product code for SPIROCAL?

The FDA product code for SPIROCAL is BXX.

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Other records listing Equilibrated Bio Systems, 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.

K892705EBS2605 INFANT HUGGERK855102MONARK 869 ERGOMETERK843996TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLERK790410ADULT ZEE-FRAMEK781509ZEE-FRAMEK781386EBS 775 TONOMETER

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Related Devices (Code: BXX)

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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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