510(k) K171954
- Device
- ClearLine IV
- Applicant
- ClearLine MD
- 510(k) number
- K171954
- Product code
- OKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-25
- Date received
- 2017-06-29
- Regulation
- 880.5445
- Classification name
- Intravascular Administration Set, Automated Air Removal System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rick Romeo
- Address
- 300 Tradecenter, Suite 5400 Woburn MA US 01801 01801
Source Documents#
Other 510(k) Records For Product Code OKL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN080009 | AIRPURGE | Anesthesia Safety Products, LLC | 2014-03-04 |
Legacy Summary#
summary
FDA Review#
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