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FDA 510(k)

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300

K-Number: K951259 · 1995-06-20

ApplicantImpulso Trading Co.
Decision Date1995-06-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 is the device name listed in this FDA 510(k) record. The listed applicant is Impulso Trading Co.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K951259. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300?

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Impulso Trading Co.. The 510(k) number is K951259.

When did ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 receive FDA 510(k) clearance?

ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 received FDA 510(k) clearance on 1995-06-20, under 510(k) number K951259.

Who is the listed applicant for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300?

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

What is the FDA product code for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300?

The FDA product code for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 is CAF.

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Official Source

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