FDA 510(k)

FLUTTER(R)

K-Number: K946083 · 1995-03-13

ApplicantBradstreet Clinical Research Assoc., Inc.

Decision Date1995-03-13

Product CodeBYI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FLUTTER(R) is the device name listed in this FDA 510(k) record. The listed applicant is Bradstreet Clinical Research Assoc., Inc.. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K946083. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUTTER(R)?

FLUTTER(R) is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Bradstreet Clinical Research Assoc., Inc.. The 510(k) number is K946083.

When did FLUTTER(R) receive FDA 510(k) clearance?

FLUTTER(R) received FDA 510(k) clearance on 1995-03-13, under 510(k) number K946083.

Who is the listed applicant for FLUTTER(R)?

The FDA 510(k) record lists Bradstreet Clinical Research Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUTTER(R)?

The FDA product code for FLUTTER(R) is BYI.

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Other records listing Bradstreet Clinical Research Assoc., Inc. as applicant

K972859FLUTTER D K951182RYDER CONTACT LENS CASE MODEL 10670 K951181RYDER CONTACT LENS CASE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.