PSA SERIES— 510(k) K123916
UnknownOsypka Medical, Inc.
FDA 510(k) clearance K123916 for PSA SERIES, Unknown on 2013-04-09. Applicant: Osypka Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Osypka Medical, Inc.
- Product code
- Code DTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.3600
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- La Jolla, CA, US
Recent devices under product code DTE
view allMore clearances from Osypka Medical, Inc.
view all- K082242 — ICON, MODEL C3
- K081035 — AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
- K070985 — AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
- K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR
- K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
Adverse events under product code DTE
product code DTE- Death
- 18
- Injury
- 247
- Malfunction
- 4,603
- Total
- 4,868
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.