Gas Module Se, Model 0998-00-0481-02
FDA 510(k) K062754 · Datascope Corp.
510(k) numberK062754
Submission
- Device name
- Gas Module Se, Model 0998-00-0481-02
- Applicant
- Datascope Corp.
Mahwh, NJ, US - Received
- September 14, 2006
- Decision date
- November 2, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
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| K092217 | Mercury VCO2BZK · Special | Respironics Novametrix, Inc. | 08/21/2009SE |
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Questions and answers
When was Gas Module Se, Model 0998-00-0481-02 cleared by the FDA?
Gas Module Se, Model 0998-00-0481-02 (K062754) received a 510(k) decision of Substantially Equivalent on November 2, 2006, 49 days after the submission was received.
What is the product code of K062754?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.