FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
NASAL MASK, NASAL MASK, FULL FACE MASK
K Number: K133009
·
Decision Apr 23, 2014
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
5
Review Days
210
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Basic Information
- Device Name
- NASAL MASK, NASAL MASK, FULL FACE MASK
- K Number
- K133009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BMC Medical Co., Ltd.
- Date Received
- September 25, 2013
- Decision Date
- April 23, 2014
- 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 BMC Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | Apr 29, 2026 | Substantially Equivalent |
| K242935 | Respiration Data Management Software (PAP Link PC) | Jan 15, 2025 | Substantially Equivalent |
| K213169 | BPAP System | Dec 5, 2022 | Substantially Equivalent |
| K211155 | Auto CPAP System | Mar 9, 2022 | Substantially Equivalent |