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FDA 510(k)

ACCULITE SSL

K-Number: K923619 · 1992-11-16

ApplicantMedical Alignment Systems
Decision Date1992-11-16
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCULITE SSL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Alignment Systems. It received FDA 510(k) clearance on 1992-11-16 under 510(k) number K923619. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCULITE SSL?

ACCULITE SSL is a medical device that received FDA 510(k) clearance on 1992-11-16. The listed applicant is Medical Alignment Systems. The 510(k) number is K923619.

When did ACCULITE SSL receive FDA 510(k) clearance?

ACCULITE SSL received FDA 510(k) clearance on 1992-11-16, under 510(k) number K923619.

Who is the listed applicant for ACCULITE SSL?

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

What is the FDA product code for ACCULITE SSL?

The FDA product code for ACCULITE SSL is IWE.

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 Medical Alignment Systems 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.

K884787ACCULITE-PPL 5K872841ACCULITE

Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, 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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