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FDA 510(k)

AIRVIT MODEL 8500

K-Number: K843594 · 1985-04-11

ApplicantLasermed Corp.
Decision Date1985-04-11
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AIRVIT MODEL 8500 is the device name listed in this FDA 510(k) record. The listed applicant is Lasermed Corp.. It received FDA 510(k) clearance on 1985-04-11 under 510(k) number K843594. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRVIT MODEL 8500?

AIRVIT MODEL 8500 is a medical device that received FDA 510(k) clearance on 1985-04-11. The listed applicant is Lasermed Corp.. The 510(k) number is K843594.

When did AIRVIT MODEL 8500 receive FDA 510(k) clearance?

AIRVIT MODEL 8500 received FDA 510(k) clearance on 1985-04-11, under 510(k) number K843594.

Who is the listed applicant for AIRVIT MODEL 8500?

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

What is the FDA product code for AIRVIT MODEL 8500?

The FDA product code for AIRVIT MODEL 8500 is HQE.

Related Clinical Trials

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Other records listing Lasermed Corp. 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.

K833532OCULASE 514 OPHTHALMIC ARGON LASERK828583LASERMED OCULASE ARGON LASER

Related Devices (Code: HQE)

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

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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