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FDA 510(k)

CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202

K-Number: K091794 · 2010-01-28

ApplicantSteve Islava
Decision Date2010-01-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 is the device name listed in this FDA 510(k) record. The listed applicant is Steve Islava. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K091794. 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 CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202?

CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Steve Islava. The 510(k) number is K091794.

When did CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 receive FDA 510(k) clearance?

CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 received FDA 510(k) clearance on 2010-01-28, under 510(k) number K091794.

Who is the listed applicant for CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202?

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

What is the FDA product code for CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202?

The FDA product code for CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 is CAF.

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Related Devices (Code: CAF)

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Official Source

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