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FDA 510(k)

LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20

K-Number: K993668 · 1999-12-20

ApplicantLaerdal Medical A/S
Decision Date1999-12-20
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical A/S. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K993668. 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 LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20?

LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Laerdal Medical A/S. The 510(k) number is K993668.

When did LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 receive FDA 510(k) clearance?

LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 received FDA 510(k) clearance on 1999-12-20, under 510(k) number K993668.

Who is the listed applicant for LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20?

The FDA 510(k) record lists Laerdal Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20?

The FDA product code for LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 is BTA.

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Other records listing Laerdal Medical A/S 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.

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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.

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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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