FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K Number: K052743
·
Decision Dec 22, 2005
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
19
Review Days
83
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Basic Information
- Device Name
- DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
- K Number
- K052743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dynarex Corp.
- Date Received
- September 30, 2005
- Decision Date
- December 22, 2005
- Product Code
- CBP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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Other Clearances by Dynarex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE | Nov 9, 2005 | Substantially Equivalent |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 | Oct 17, 2002 | Substantially Equivalent |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Mar 6, 2002 | Substantially Equivalent |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Nov 28, 2001 | Substantially Equivalent |
| K991695 | DYNAREX NON-WOVEN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K991694 | DYNAREX DRAIN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dec 11, 1998 | Substantially Equivalent |
| K960388 | DYNAREX NON-WOVEN SPONGE | Apr 1, 1996 | Substantially Equivalent |
| K951660 | DYNAREX GAUZE SPONGE | May 9, 1995 | Substantially Equivalent |
| K933308 | DYNAREX GAUZE SPONGE OR PADS | Dec 22, 1993 | Substantially Equivalent |