FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOOKER BOX, MODEL PAD 5010
K Number: K993205
·
Decision Jul 20, 2000
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
15
Review Days
300
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Basic Information
- Device Name
- BOOKER BOX, MODEL PAD 5010
- K Number
- K993205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tz Medical, Inc.
- Date Received
- September 24, 1999
- Decision Date
- July 20, 2000
- Product Code
- LDD
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | Dec 15, 2006 | Substantially Equivalent |
| K040208 | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | May 11, 2004 | Substantially Equivalent |
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| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Sep 15, 1999 | Substantially Equivalent |