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FDA 510(k)

MANIFOLD KIT

K-Number: K780364 · 1978-03-30

ApplicantSpica, Inc.
Decision Date1978-03-30
Product CodeCAN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MANIFOLD KIT is the device name listed in this FDA 510(k) record. The listed applicant is Spica, Inc.. It received FDA 510(k) clearance on 1978-03-30 under 510(k) number K780364. 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 MANIFOLD KIT?

MANIFOLD KIT is a medical device that received FDA 510(k) clearance on 1978-03-30. The listed applicant is Spica, Inc.. The 510(k) number is K780364.

When did MANIFOLD KIT receive FDA 510(k) clearance?

MANIFOLD KIT received FDA 510(k) clearance on 1978-03-30, under 510(k) number K780364.

Who is the listed applicant for MANIFOLD KIT?

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

What is the FDA product code for MANIFOLD KIT?

The FDA product code for MANIFOLD KIT is CAN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spica, 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.

K800801ANALGESIA UNITS, OXYGEN & NITRATE DEVICEK780365OXYGEN/NITROUS OXIDE OUTLET

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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