FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
K Number: K100310
·
Decision Oct 13, 2010
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
59
Applicant Total
42
Review Days
252
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Basic Information
- Device Name
- BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
- K Number
- K100310
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BTL Industries, Inc.
- Date Received
- February 3, 2010
- Decision Date
- October 13, 2010
- Product Code
- MWJ
- 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 |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | FDA class 2 | Cardiovascular |
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Other Clearances by BTL Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252963 | BTL-899TT | Jun 12, 2026 | Substantially Equivalent |
| K253750 | BTL-785NEH | Mar 17, 2026 | Substantially Equivalent |
| K252561 | BTL-754FF | Feb 18, 2026 | Substantially Equivalent |
| K250309 | BTL-199 | Aug 7, 2025 | Substantially Equivalent |
| K243290 | BTL-785MJ | May 9, 2025 | Substantially Equivalent |
| K241516 | BTL-398 | Feb 10, 2025 | Substantially Equivalent |
| K241270 | BTL-754 | Jan 30, 2025 | Substantially Equivalent |
| K242532 | BTL-785BNF-E | Dec 13, 2024 | Substantially Equivalent |
| K240234 | BTL-899MS | Aug 17, 2024 | Substantially Equivalent |
| K233849 | BTL-499 | Apr 23, 2024 | Substantially Equivalent |