Model 2120 Spiroscreen
FDA 510(k) K854403 · Gould, Inc.
510(k) numberK854403
Submission
- Device name
- Model 2120 Spiroscreen
- Applicant
- Gould, Inc.
Dayton, OH, US - Received
- October 31, 1985
- Decision date
- January 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K843970 | Model IM1074 End-Tidal CO2 ModuleCCK · Traditional | 10/24/1984SE |
Questions and answers
When was Model 2120 Spiroscreen cleared by the FDA?
Model 2120 Spiroscreen (K854403) received a 510(k) decision of Substantially Equivalent on January 14, 1986, 75 days after the submission was received.
What is the product code of K854403?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.