FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUF-COVER (TM)
K Number: K031195
·
Decision Oct 10, 2003
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
19
Review Days
177
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Basic Information
- Device Name
- CUF-COVER (TM)
- K Number
- K031195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ethox Corp.
- Date Received
- April 16, 2003
- Decision Date
- October 10, 2003
- Product Code
- DXQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
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Other Clearances by Ethox Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K040286 | ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS | Mar 15, 2004 | Substantially Equivalent |
| K962850 | TUM-E-VAC | Feb 21, 1997 | Substantially Equivalent |
| K935633 | NO-MES | Sep 30, 1994 | Substantially Equivalent |
| K921946 | TUM-E-VAC BITE BLOCK | Dec 9, 1992 | Substantially Equivalent |
| K885220 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT | Sep 25, 1989 | Unknown |
| K894927 | SURGI SQUEEZ | Sep 11, 1989 | Substantially Equivalent |
| K883977 | SURGI-CUF STERILE/NON-STERILE DISPOSABLE | Feb 10, 1989 | Substantially Equivalent |
| K860599 | ETHOX LAVAGE TUBE | Mar 11, 1986 | Substantially Equivalent |
| K844988 | ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. | Apr 4, 1985 | Substantially Equivalent |
| K841512 | ETHOX RELIA-FLO 2001 ENTERAL FEED | May 21, 1984 | Substantially Equivalent |