FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESA620 ELECTRICAL SAFETY ANALYZER
K Number: K121722
·
Decision Oct 11, 2012
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
6
Review Days
121
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Basic Information
- Device Name
- ESA620 ELECTRICAL SAFETY ANALYZER
- K Number
- K121722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fluke Biomedical
- Date Received
- June 12, 2012
- Decision Date
- October 11, 2012
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Fluke Biomedical
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|---|---|---|---|
| K121860 | ESA615 | Jan 25, 2013 | Substantially Equivalent |
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| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Apr 13, 2011 | Substantially Equivalent |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Dec 24, 2008 | Substantially Equivalent |
| K072114 | IMPULSE 6000D/7000DP | Jan 28, 2008 | Substantially Equivalent |