FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRAM-MA NEONATAL SC
K Number: K853475
·
Decision Sep 5, 1985
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
47
Applicant Total
6
Review Days
16
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Basic Information
- Device Name
- GRAM-MA NEONATAL SC
- K Number
- K853475
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2720
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kentec Medical, Inc.
- Date Received
- August 20, 1985
- Decision Date
- September 5, 1985
- Product Code
- FRW
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRW | Scale, Patient | FDA class 1 | General Hospital |
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Other Clearances by Kentec Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET | Feb 17, 2012 | Substantially Equivalent |
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | Apr 22, 2010 | Substantially Equivalent |
| K050443 | ACCU-LEAD | Sep 2, 2005 | Substantially Equivalent |
| K970686 | ACCUTEMP-PROBE | Aug 25, 1997 | Substantially Equivalent |
| K960080 | ACCUTEMP PROBE | May 1, 1996 | Substantially Equivalent |