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FDA 510(k)

DELTA

K-Number: K945117 · 1997-02-28

ApplicantPelton & Crane Co.
Decision Date1997-02-28
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DELTA is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K945117. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA?

DELTA is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Pelton & Crane Co.. The 510(k) number is K945117.

When did DELTA receive FDA 510(k) clearance?

DELTA received FDA 510(k) clearance on 1997-02-28, under 510(k) number K945117.

Who is the listed applicant for DELTA?

The FDA 510(k) record lists Pelton & Crane Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTA?

The FDA product code for DELTA is FLE.

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Other records listing Pelton & Crane Co. 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.

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Related Devices (Code: FLE)

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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