Gem; Hawk; Eagle; Models 004110, 0044120, 004130

FDA 510(k) K030917 · Collins Medical, Inc.

Substantially Equivalent

510(k) numberK030917

Submission

Device name
Gem; Hawk; Eagle; Models 004110, 0044120, 004130
Applicant
Collins Medical, Inc.
Braintree, MA, US
Received
March 24, 2003
Decision date
May 14, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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More from Vitalograph Ireland, Ltd.

510(k)DeviceDecision
K030464Gem, Model 004110BZG · Special 03/14/2003SE
K011344Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400BZC · Abbreviated 05/17/2002SE
K992743Collins CPLBZG · Special 09/13/1999SE

Questions and answers

When was Gem; Hawk; Eagle; Models 004110, 0044120, 004130 cleared by the FDA?

Gem; Hawk; Eagle; Models 004110, 0044120, 004130 (K030917) received a 510(k) decision of Substantially Equivalent on May 14, 2003, 51 days after the submission was received.

What is the product code of K030917?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.