510(k) K151776
- Device
- Central Venous Pressure System
- Applicant
- Mespere LifeSciences Inc.
- 510(k) number
- K151776
- Product code
- PFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-12
- Date received
- 2015-07-01
- Regulation
- 870.1140
- Classification name
- Non-invasive Central Venous Manometer
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Helen Tan
- Address
- 180 Frobisher Dr., Unit 1c Waterloo CA N2V 2A2 N2V 2A2
FDA Registration Numbers#
- 3010521858
Source Documents#
Other 510(k) Records For Product Code PFA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131085 | CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 | Mespere Lifesciences, Inc. | 2013-08-22 |
Legacy Summary#
summary
FDA Review#
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