FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Model 330 Multifunction Aspirator
K Number: K170533
·
Decision Apr 18, 2017
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
30
Review Days
54
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Model 330 Multifunction Aspirator
- K Number
- K170533
- 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
- ZOLL Medical Corporation
- Date Received
- February 23, 2017
- Decision Date
- April 18, 2017
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Suction Pump (SU-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by ZOLL Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K233486 | 731 Series Ventilator | Dec 13, 2024 | Substantially Equivalent |
| K202375 | ZOLL Propaq M | Mar 9, 2021 | Substantially Equivalent |
| K180482 | ZOLL Propaq M | Nov 30, 2018 | Substantially Equivalent |
| K172653 | Power Infuser | Jul 18, 2018 | Substantially Equivalent |
| K162832 | 731 Series Ventilators | Aug 2, 2017 | Substantially Equivalent |
| K142915 | ZOLL X Series | Dec 3, 2014 | Substantially Equivalent |
| K141774 | ZOLL X SERIES | Nov 19, 2014 | Substantially Equivalent |
| K140502 | ZOLL E SERIES ALS | Nov 6, 2014 | Substantially Equivalent |
| K132488 | ZOLL CODE WRITER | Apr 3, 2014 | Substantially Equivalent |
| K131919 | ZOLL EPCR IOS | Dec 17, 2013 | Substantially Equivalent |