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FDA 510(k)

ACCULITE-PPL 5

K-Number: K884787 · 1989-01-24

ApplicantMedical Alignment Systems
Decision Date1989-01-24
Product CodeINE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACCULITE-PPL 5 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 1989-01-24 under 510(k) number K884787. The device is classified under product code INE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCULITE-PPL 5?

ACCULITE-PPL 5 is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Medical Alignment Systems. The 510(k) number is K884787.

When did ACCULITE-PPL 5 receive FDA 510(k) clearance?

ACCULITE-PPL 5 received FDA 510(k) clearance on 1989-01-24, under 510(k) number K884787.

Who is the listed applicant for ACCULITE-PPL 5?

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-PPL 5?

The FDA product code for ACCULITE-PPL 5 is INE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K923619ACCULITE SSLK872841ACCULITE

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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