POCKETCPR— 510(k) K071321
Substantially EquivalentBio-Detek, Inc.
FDA 510(k) clearance K071321 for POCKETCPR, Substantially Equivalent on 2007-09-12. Applicant: Bio-Detek, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Detek, Inc.
- Product code
- Code LIX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pawtucket, RI, US
Recent devices under product code LIX
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- K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
- K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE
- K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
- K040056 — BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
Adverse events under product code LIX
product code LIX- Other
- 2
- Total
- 2
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.