FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
K Number: K981802
·
Decision Nov 25, 1998
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
17
Review Days
188
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Basic Information
- Device Name
- ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
- K Number
- K981802
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Detek, Inc.
- Date Received
- May 21, 1998
- Decision Date
- November 25, 1998
- Product Code
- MKJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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Other Clearances by Bio-Detek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | May 2, 2015 | Substantially Equivalent |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | May 2, 2015 | Substantially Equivalent |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | Oct 10, 2014 | Substantially Equivalent |
| K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 | Nov 16, 2010 | Substantially Equivalent |
| K071321 | POCKETCPR | Sep 12, 2007 | Substantially Equivalent |
| K040256 | PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 | Apr 9, 2004 | Substantially Equivalent |
| K040056 | BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 | Apr 9, 2004 | Substantially Equivalent |
| K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR | Feb 27, 2004 | Substantially Equivalent |
| K984582 | ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX | Mar 16, 1999 | Substantially Equivalent |
| K990106 | ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES | Feb 26, 1999 | Substantially Equivalent |