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FDA 510(k)

EASY-JET DEVICE

K-Number: K972383 · 1999-11-23

ApplicantA.Stein - Regulatory Affairs Consulting
Decision Date1999-11-23
Product CodeKLZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EASY-JET DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is A.Stein - Regulatory Affairs Consulting. It received FDA 510(k) clearance on 1999-11-23 under 510(k) number K972383. The device is classified under product code KLZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-JET DEVICE?

EASY-JET DEVICE is a medical device that received FDA 510(k) clearance on 1999-11-23. The listed applicant is A.Stein - Regulatory Affairs Consulting. The 510(k) number is K972383.

When did EASY-JET DEVICE receive FDA 510(k) clearance?

EASY-JET DEVICE received FDA 510(k) clearance on 1999-11-23, under 510(k) number K972383.

Who is the listed applicant for EASY-JET DEVICE?

The FDA 510(k) record lists A.Stein - Regulatory Affairs Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY-JET DEVICE?

The FDA product code for EASY-JET DEVICE is KLZ.

Related Clinical Trials

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Other records listing A.Stein - Regulatory Affairs Consulting 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.

K973592WALKCARE P200 SYSTEMK982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)K973590HEMORRELIEF DEVICEK973148MACOM

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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