FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETASCAN 2000,2000A OBSTETRICAL DATA
K Number: K813457
·
Decision Feb 12, 1982
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- FETASCAN 2000,2000A OBSTETRICAL DATA
- K Number
- K813457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Cranbury Medical Labs, Inc.
- Date Received
- December 10, 1981
- Decision Date
- February 12, 1982
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Cranbury Medical Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K828586 | ENTREKIN MODEL DX-300 CONTINUOUS WAVE ULTRASONIC DOPPLER TRANSDUCER | Dec 14, 1982 | Substantially Equivalent |
| K822830 | MEDICAL LABS FETAL SCAN #1000 W/CENTRAL | Sep 30, 1982 | Substantially Equivalent |
| K827718 | UNKNOWN | Aug 16, 1982 | Substantially Equivalent |
| K827375 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A | Jul 2, 1982 | Substantially Equivalent |
| K827376 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800 | Jul 2, 1982 | Substantially Equivalent |
| K813458 | FETASCAN 1000, 1000A OBSTETRICAL DATA | Jan 28, 1982 | Substantially Equivalent |