FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BSI MODEL TIP
K Number: K897191
·
Decision Jul 13, 1990
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
40
Applicant Total
3
Review Days
197
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Basic Information
- Device Name
- BSI MODEL TIP
- K Number
- K897191
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.2980
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Bales Scientific, Inc.
- Date Received
- December 28, 1989
- Decision Date
- July 13, 1990
- 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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