Gas Module 3
FDA 510(k) K180788 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) numberK180788
Submission
- Device name
- Gas Module 3
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- March 26, 2018
- Decision date
- October 24, 2018
- 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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Questions and answers
When was Gas Module 3 cleared by the FDA?
Gas Module 3 (K180788) received a 510(k) decision of Substantially Equivalent on October 24, 2018, 212 days after the submission was received.
What is the product code of K180788?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.