FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
K Number: K193191
·
Decision Nov 20, 2020
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
1
Review Days
367
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Basic Information
- Device Name
- MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
- K Number
- K193191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Weinmann Emergency Medical Technology GmbH + Co. KG
- Date Received
- November 19, 2019
- Decision Date
- November 20, 2020
- Product Code
- BTL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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