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FDA 510(k)

PROBE, UPTAKE, NUCLEAR

K-Number: K864624 · 1987-08-10

ApplicantCarolina Medical Electronics
Decision Date1987-08-10
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROBE, UPTAKE, NUCLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical Electronics. It received FDA 510(k) clearance on 1987-08-10 under 510(k) number K864624. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROBE, UPTAKE, NUCLEAR?

PROBE, UPTAKE, NUCLEAR is a medical device that received FDA 510(k) clearance on 1987-08-10. The listed applicant is Carolina Medical Electronics. The 510(k) number is K864624.

When did PROBE, UPTAKE, NUCLEAR receive FDA 510(k) clearance?

PROBE, UPTAKE, NUCLEAR received FDA 510(k) clearance on 1987-08-10, under 510(k) number K864624.

Who is the listed applicant for PROBE, UPTAKE, NUCLEAR?

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

What is the FDA product code for PROBE, UPTAKE, NUCLEAR?

The FDA product code for PROBE, UPTAKE, NUCLEAR is IZO.

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Other records listing Carolina Medical Electronics as applicant

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Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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