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FDA 510(k)

AEROTEE, MODEL # 1001

K-Number: K982408 · 1998-09-14

ApplicantPiper Medical Products
Decision Date1998-09-14
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AEROTEE, MODEL # 1001 is the device name listed in this FDA 510(k) record. The listed applicant is Piper Medical Products. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982408. 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 AEROTEE, MODEL # 1001?

AEROTEE, MODEL # 1001 is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Piper Medical Products. The 510(k) number is K982408.

When did AEROTEE, MODEL # 1001 receive FDA 510(k) clearance?

AEROTEE, MODEL # 1001 received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982408.

Who is the listed applicant for AEROTEE, MODEL # 1001?

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

What is the FDA product code for AEROTEE, MODEL # 1001?

The FDA product code for AEROTEE, MODEL # 1001 is CAF.

Related Clinical Trials

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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Other records listing Piper Medical Products 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.

K993558EZFLOW MAX, MODEL 1007K990384EZFLOW CONTINUOUS NEBULIZER,MODEL 1005

Related Devices (Code: CAF)

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

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