FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GASTRIC AND RECTAL CATHETERS
K Number: K973844
·
Decision Jun 4, 1999
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
2
Review Days
604
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Basic Information
- Device Name
- GASTRIC AND RECTAL CATHETERS
- K Number
- K973844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- G & J Electronics, Inc.
- Date Received
- October 8, 1997
- Decision Date
- June 4, 1999
- Product Code
- FFX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by G & J Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991288 | DISTENDER SERIES II BAROSTAT | Jun 8, 1999 | Substantially Equivalent |