Disposable Transpac III Integrated Transducer (It)
FDA 510(k) K052828 · Hospira, Inc.
510(k) numberK052828
Submission
- Device name
- Disposable Transpac III Integrated Transducer (It)
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- October 5, 2005
- Decision date
- February 17, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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| K160492 | Hospira Sapphire SetsMRZ · Traditional | 12/06/2016SE |
| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | 04/08/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
Questions and answers
When was Disposable Transpac III Integrated Transducer (It) cleared by the FDA?
Disposable Transpac III Integrated Transducer (It) (K052828) received a 510(k) decision of Substantially Equivalent on February 17, 2006, 135 days after the submission was received.
What is the product code of K052828?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.