FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
K Number: K120035
·
Decision May 16, 2012
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
30
Review Days
133
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Basic Information
- Device Name
- APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
- K Number
- K120035
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex Medical Corp.
- Date Received
- January 4, 2012
- Decision Date
- May 16, 2012
- 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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|---|---|---|---|
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| K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | Oct 6, 2014 | Substantially Equivalent |
| K121642 | WIZARD 230 NASAL PILOW MASK | Jun 6, 2013 | Substantially Equivalent |
| K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 | Dec 6, 2012 | Substantially Equivalent |
| K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | May 6, 2011 | Substantially Equivalent |
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| K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 | Apr 22, 2009 | Substantially Equivalent |