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FDA 510(k)

SEA MEDICAL PRODUCTS LO-VOL

K-Number: K811847 · 1981-07-13

ApplicantSea Medical Products, Inc.
Decision Date1981-07-13
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEA MEDICAL PRODUCTS LO-VOL is the device name listed in this FDA 510(k) record. The listed applicant is Sea Medical Products, Inc.. It received FDA 510(k) clearance on 1981-07-13 under 510(k) number K811847. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEA MEDICAL PRODUCTS LO-VOL?

SEA MEDICAL PRODUCTS LO-VOL is a medical device that received FDA 510(k) clearance on 1981-07-13. The listed applicant is Sea Medical Products, Inc.. The 510(k) number is K811847.

When did SEA MEDICAL PRODUCTS LO-VOL receive FDA 510(k) clearance?

SEA MEDICAL PRODUCTS LO-VOL received FDA 510(k) clearance on 1981-07-13, under 510(k) number K811847.

Who is the listed applicant for SEA MEDICAL PRODUCTS LO-VOL?

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

What is the FDA product code for SEA MEDICAL PRODUCTS LO-VOL?

The FDA product code for SEA MEDICAL PRODUCTS LO-VOL is FPK.

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.

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Other records listing Sea Medical Products, 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.

K811561LO-VOL I.V. SETS

Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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