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FDA 510(k)

DOSER

K-Number: K935955 · 1994-09-16

ApplicantNewmed Corp.
Decision Date1994-09-16
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DOSER is the device name listed in this FDA 510(k) record. The listed applicant is Newmed Corp.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K935955. 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 DOSER?

DOSER is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Newmed Corp.. The 510(k) number is K935955.

When did DOSER receive FDA 510(k) clearance?

DOSER received FDA 510(k) clearance on 1994-09-16, under 510(k) number K935955.

Who is the listed applicant for DOSER?

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

What is the FDA product code for DOSER?

The FDA product code for DOSER is CAF.

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Other records listing Newmed Corp. 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.

K955887NEWMED ABP-LITE

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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