FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEEP VALVE
K Number: K902062
·
Decision Sep 4, 1990
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
33
Review Days
119
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Basic Information
- Device Name
- PEEP VALVE
- K Number
- K902062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Date Received
- May 8, 1990
- Decision Date
- September 4, 1990
- Product Code
- BYE
- 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 |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
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Other Clearances by Hudson Oxygen Therapy Sales Co.
| K Number | Device Name | ||
|---|---|---|---|
| K900783 | MDI ADAPTOR | Jul 18, 1990 | Substantially Equivalent |
| K900470 | IN-THE NEBULIZER | May 18, 1990 | Substantially Equivalent |
| K895589 | MANUAL RESUSCITATOR | Mar 30, 1990 | Substantially Equivalent |
| K896136 | INFANT C.P.A.P. MONITOR | Jan 9, 1990 | Substantially Equivalent |
| K895231 | CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER | Oct 27, 1989 | Substantially Equivalent |
| K895747 | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR | Oct 27, 1989 | Substantially Equivalent |
| K890035 | BACTERIA FILTER | May 5, 1989 | Substantially Equivalent |
| K870895 | NO. 1552, VALVED VENTI-COMP | May 4, 1987 | Substantially Equivalent |
| K871157 | C.P.A.P. NASAL CANNULA | Apr 21, 1987 | Substantially Equivalent |
| K870138 | 1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE | Mar 6, 1987 | Substantially Equivalent |