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FDA 510(k)

C-LITE

K-Number: K841589 · 1984-05-22

ApplicantSuncoast Medical Manufacturers, Inc.
Decision Date1984-05-22
Product CodeKYT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

C-LITE is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Medical Manufacturers, Inc.. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K841589. The device is classified under product code KYT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-LITE?

C-LITE is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Suncoast Medical Manufacturers, Inc.. The 510(k) number is K841589.

When did C-LITE receive FDA 510(k) clearance?

C-LITE received FDA 510(k) clearance on 1984-05-22, under 510(k) number K841589.

Who is the listed applicant for C-LITE?

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

What is the FDA product code for C-LITE?

The FDA product code for C-LITE is KYT.

Other records listing Suncoast Medical Manufacturers, 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.

K841603ADJUST-A-TEMP MICROK841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.K841604ADJUST-A-TEMP HIGH TEMPERATUREK841459REPLACE-A-TIP ADJUST. LOW TEMP.-K841591PYRO-TIPK840376SURG-A STAT LOOP TIP

View all 31 devices →

Related Devices (Code: KYT)

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.

K920782OLYMPIC TRANS-LITEOlympic Medical Corp.K841588SUN-LITE WHITE SPOTSuncoast Medical Manufacturers, Inc.K791001PENLIGHT/SWAB HOLDERConcept, Inc.K781228PENLIGHTSAbco Dealers, Inc.K760972TYCOS DIAGNOSTIC PENLIGHTTaylor Instrument Analytics Co.

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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