FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
AERO-CLICK
K Number: K993094
·
Decision Oct 23, 2000
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
3
Review Days
403
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Basic Information
- Device Name
- AERO-CLICK
- K Number
- K993094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Map Medizintechnik Fur Arzt Und Patient GmbH
- Date Received
- September 16, 1999
- Decision Date
- October 23, 2000
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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