FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
K Number: K101641
·
Decision Jun 16, 2011
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
4
Review Days
371
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Basic Information
- Device Name
- AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
- K Number
- K101641
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.2980
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ag Digital Technology Corp.
- Date Received
- June 10, 2010
- Decision Date
- June 16, 2011
- Product Code
- LHQ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LHQ | System, Telethermographic (Adjunctive Use) | FDA class 1 | Obstetrics/Gynecology |
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