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FDA 510(k)

PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP

K-Number: K884133 · 1989-03-08

ApplicantPreemicare Corp.
Decision Date1989-03-08
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1989-03-08 under 510(k) number K884133. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP?

PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP is a medical device that received FDA 510(k) clearance on 1989-03-08. The listed applicant is Preemicare Corp.. The 510(k) number is K884133.

When did PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP receive FDA 510(k) clearance?

PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP received FDA 510(k) clearance on 1989-03-08, under 510(k) number K884133.

Who is the listed applicant for PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP?

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

What is the FDA product code for PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP?

The FDA product code for PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP is LBI.

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Other records listing Preemicare 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.

K911450INFANT VENTILATORK896375PREEMICARE NEBUTECH NEBULIZER SYSTEMK900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATORK893622PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.K893624PREEMICARE MODEL 2500 TRANSPORT WARMERK891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 275

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Related Devices (Code: LBI)

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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