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FDA 510(k)

PULSAR EM

K-Number: K882816 · 1989-04-27

ApplicantApex Medical, Inc.
Decision Date1989-04-27
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PULSAR EM is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical, Inc.. It received FDA 510(k) clearance on 1989-04-27 under 510(k) number K882816. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSAR EM?

PULSAR EM is a medical device that received FDA 510(k) clearance on 1989-04-27. The listed applicant is Apex Medical, Inc.. The 510(k) number is K882816.

When did PULSAR EM receive FDA 510(k) clearance?

PULSAR EM received FDA 510(k) clearance on 1989-04-27, under 510(k) number K882816.

Who is the listed applicant for PULSAR EM?

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

What is the FDA product code for PULSAR EM?

The FDA product code for PULSAR EM is ILX.

Related Clinical Trials

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Other records listing Apex Medical, 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.

K933965APEX MEDICAL AIR PUMPSK902102COM-TENS: A NEUROSTIMULATORK882468ELIMINATOR AIR FILTERK871570APEX ALPHA VACUUM PUMPK871384APEX SUCTION CURETTE

Related Devices (Code: ILX)

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.

K241395Active System; Avenue8Caerus CorporationK202337Pulsed electromagnetic field wrapHi-Dow International, Inc.K190251RecoveryRxBioelectronics CorporationK131979PROVANT THERAPY SYSTEMRegenesis Biomedical, Inc.K121702ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICEOrthocor MedicalK121338ZEOBIIvivi Health Science, LLC

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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