FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 205 SHOCK-TRODE
K Number: K910661
·
Decision May 2, 1991
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
83
Applicant Total
27
Review Days
78
Basic Information
- Device Name
- MODEL 205 SHOCK-TRODE
- K Number
- K910661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5550
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CARDIOTRONICS, INC.
- Date Received
- February 13, 1991
- Decision Date
- May 2, 1991
- Product Code
- DRO
- 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | FDA class 2 | Cardiovascular |
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Other Clearances by CARDIOTRONICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K932903 | EKG VEST | Feb 24, 1995 | Substantially Equivalent |
| K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE | Dec 1, 1992 | Substantially Equivalent |
| K923297 | MODEL #340 STEALTH-TRODE+LS | Sep 18, 1992 | Substantially Equivalent |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | Jun 11, 1992 | Substantially Equivalent |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | Jun 11, 1992 | Substantially Equivalent |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | Jun 11, 1992 | Substantially Equivalent |
| K921606 | MODEL #125 CHILD STIMULATION PADS | May 26, 1992 | Substantially Equivalent |
| K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS | Feb 3, 1992 | Substantially Equivalent |
| K914725 | COORDINATOR, CABLE INPUT | Nov 5, 1991 | Substantially Equivalent |
| K912621 | MODEL #911 STEALTH MULTI PADS | Oct 16, 1991 | Substantially Equivalent |