BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX— 510(k) K981745
Substantially EquivalentSunscope Intl., Inc.
FDA 510(k) clearance K981745 for BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX, Substantially Equivalent on 1998-07-17. Applicant: Sunscope Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Sunscope Intl., Inc.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newport Beach, CA, US
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- K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Sunscope Intl., Inc.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.