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FDA 510(k)

MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U

K-Number: K900170 · 1990-07-25

ApplicantElscint, Inc.
Decision Date1990-07-25
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1990-07-25 under 510(k) number K900170. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U?

MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U is a medical device that received FDA 510(k) clearance on 1990-07-25. The listed applicant is Elscint, Inc.. The 510(k) number is K900170.

When did MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U receive FDA 510(k) clearance?

MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U received FDA 510(k) clearance on 1990-07-25, under 510(k) number K900170.

Who is the listed applicant for MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U?

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

What is the FDA product code for MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U?

The FDA product code for MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U is JAK.

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Other records listing Elscint, Inc. as applicant

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Related Devices (Code: JAK)

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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