Aesculon CHF, Hypertension & Pacemaker Clinic
FDA 510(k) K070985 · Osypka Medical, Inc.
510(k) numberK070985
Submission
- Device name
- Aesculon CHF, Hypertension & Pacemaker Clinic
- Applicant
- Osypka Medical, Inc.
La Jolla, CA, US - Received
- April 6, 2007
- Decision date
- February 1, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
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| K123916 | Psa SeriesDTE · Traditional | 04/09/2013SESK |
| K082242 | Icon, Model C3DSB · Special | 10/08/2008SE |
| K081035 | Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…DSB · Special | 05/30/2008SE |
| K033130 | Pace 101/PACE 101H, Model 3077 Ssi Temporary Pulse GeneratorDTE · Special | 10/31/2003SE |
| K022939 | Oscor Pace 101/101H and Accessories, St.Jude Medical Model 3077 and…DTE · Special | 10/03/2002SE |
| K020896 | Oscor Pace 203/PACE 203H Dual-Chamber Temporary Pacemaker, St. Jude Medical, Model 3085…DTE · Abbreviated | 06/14/2002SE |
Questions and answers
When was Aesculon CHF, Hypertension & Pacemaker Clinic cleared by the FDA?
Aesculon CHF, Hypertension & Pacemaker Clinic (K070985) received a 510(k) decision of Substantially Equivalent on February 1, 2008, 301 days after the submission was received.
What is the product code of K070985?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.