FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL CANNULA
K Number: K935533
·
Decision Feb 3, 1994
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
24
Review Days
79
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Basic Information
- Device Name
- NASAL CANNULA
- K Number
- K935533
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Puritas Health Care, Inc.
- Date Received
- November 16, 1993
- Decision Date
- February 3, 1994
- Product Code
- CAT
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
FDA 510(k)
FDA Class 1
·Anesthesiology
4 SURE TM NASAL OXYGEN CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
FDA 510(k)
FDA Class 1
·Anesthesiology
CANNULA NASAL OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
SKIN SAVER(TM) TUBING HOLDER, MODEL 467
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Puritas Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942339 | SKIN NEUVEAU SCAR TREATMENT | Nov 28, 1994 | Substantially Equivalent |
| K941197 | SILK*SKIN SCAR TREATMENT | Aug 11, 1994 | Substantially Equivalent |
| K935600 | TRACHEAL SUCTION CATHETER | May 10, 1994 | Unknown |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | May 5, 1994 | Substantially Equivalent |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Apr 21, 1994 | Substantially Equivalent |
| K940055 | MULTISET | Apr 15, 1994 | Substantially Equivalent |
| K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET | Apr 15, 1994 | Substantially Equivalent |
| K935583 | SUCTION SET, TRACHAEL | Apr 11, 1994 | Unknown |
| K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM | Apr 4, 1994 | Substantially Equivalent |
| K935532 | TRANSFER SET | Apr 4, 1994 | Substantially Equivalent |