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FDA 510(k)

LO-VOL I.V. SETS

K-Number: K811561 · 1981-06-26

ApplicantSea Medical Products, Inc.
Decision Date1981-06-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LO-VOL I.V. SETS 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 1981-06-26 under 510(k) number K811561. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LO-VOL I.V. SETS?

LO-VOL I.V. SETS is a medical device that received FDA 510(k) clearance on 1981-06-26. The listed applicant is Sea Medical Products, Inc.. The 510(k) number is K811561.

When did LO-VOL I.V. SETS receive FDA 510(k) clearance?

LO-VOL I.V. SETS received FDA 510(k) clearance on 1981-06-26, under 510(k) number K811561.

Who is the listed applicant for LO-VOL I.V. SETS?

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 LO-VOL I.V. SETS?

The FDA product code for LO-VOL I.V. SETS is FPA.

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.

K811847SEA MEDICAL PRODUCTS LO-VOL

Related Devices (Code: FPA)

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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Official Source

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