Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STATVAC PORTABLE SUCTION UNIT

K-Number: K941578 · 1994-05-18

Decision Date1994-05-18
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STATVAC PORTABLE SUCTION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal California, Inc.. It received FDA 510(k) clearance on 1994-05-18 under 510(k) number K941578. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATVAC PORTABLE SUCTION UNIT?

STATVAC PORTABLE SUCTION UNIT is a medical device that received FDA 510(k) clearance on 1994-05-18. The listed applicant is Laerdal California, Inc.. The 510(k) number is K941578.

When did STATVAC PORTABLE SUCTION UNIT receive FDA 510(k) clearance?

STATVAC PORTABLE SUCTION UNIT received FDA 510(k) clearance on 1994-05-18, under 510(k) number K941578.

Who is the listed applicant for STATVAC PORTABLE SUCTION UNIT?

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

What is the FDA product code for STATVAC PORTABLE SUCTION UNIT?

The FDA product code for STATVAC PORTABLE SUCTION UNIT is BTA.

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.

Other records listing Laerdal California, 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.

Related Devices (Code: BTA)

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.

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.

↑