FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A
K Number: K827375
·
Decision Jul 2, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
80
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Basic Information
- Device Name
- BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A
- K Number
- K827375
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cranbury Medical Labs, Inc.
- Date Received
- April 13, 1982
- Decision Date
- July 2, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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 |
| K827376 | BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 800 | Jul 2, 1982 | Substantially Equivalent |
| K813457 | FETASCAN 2000,2000A OBSTETRICAL DATA | Feb 12, 1982 | Substantially Equivalent |
| K813458 | FETASCAN 1000, 1000A OBSTETRICAL DATA | Jan 28, 1982 | Substantially Equivalent |