FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K SERIES CPAP SYSTEMS
K Number: K123897
·
Decision Mar 13, 2013
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
6
Review Days
85
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Basic Information
- Device Name
- K SERIES CPAP SYSTEMS
- K Number
- K123897
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Curative Medical, Inc.
- Date Received
- December 18, 2012
- Decision Date
- March 13, 2013
- 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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Other Clearances by Curative Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141354 | NAVAJO PTA BALLOON DILATATION CATHETER | Jan 30, 2015 | Substantially Equivalent |
| K130828 | K SERIES CPAP SYSTEMS | Jan 13, 2014 | Substantially Equivalent |
| K131702 | K SERIES CPAP SYSTEMS | Dec 6, 2013 | Substantially Equivalent |
| K130663 | BESTFIT2 NASAL MASK | Sep 27, 2013 | Substantially Equivalent |
| K120285 | K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER | Jul 2, 2012 | Substantially Equivalent |