FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Nasal Aspirator (NS 13)
K Number: K241852
·
Decision Dec 31, 2024
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
27
Review Days
187
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Basic Information
- Device Name
- Nasal Aspirator (NS 13)
- K Number
- K241852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avita Corporation
- Date Received
- June 27, 2024
- Decision Date
- December 31, 2024
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTA), ordered by most recent decision date.
Momcozy Nasal Aspirator (BN007)
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Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
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Suction Pump (SU-90)
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Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
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Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
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Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
FDA 510(k)
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·General, Plastic Surgery
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| K242455 | AViTA Pulse Oximeter (SP62B) | Feb 19, 2025 | Substantially Equivalent |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Oct 22, 2024 | Substantially Equivalent |
| K223399 | AViTA Pulse Oximeter | May 20, 2024 | Substantially Equivalent |
| K200346 | Wrist Type Blood Pressure Monitor | Dec 17, 2020 | Substantially Equivalent |
| K180155 | Arm Type Blood Pressure Monitor | Aug 3, 2018 | Substantially Equivalent |
| K172427 | AViTA Radar Thermo NT16 Series IR Thermometer | Apr 19, 2018 | Substantially Equivalent |
| K112825 | AVITA ARM TYPE BLOOD PRESSURE MONITOR | Jan 18, 2012 | Substantially Equivalent |