FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
K Number: K870382
·
Decision Mar 6, 1987
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
12
Review Days
36
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Basic Information
- Device Name
- DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
- K Number
- K870382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Nova-Ventrx
- Date Received
- January 29, 1987
- Decision Date
- March 6, 1987
- 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 Nova-Ventrx
| K Number | Device Name | ||
|---|---|---|---|
| K952267 | CRITERION, CRITERION I.V., MODIFIED | Dec 2, 1997 | Substantially Equivalent |
| K954480 | CONDENSATE COLLECTION KIT | Dec 29, 1995 | Substantially Equivalent |
| K893760 | CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 | Aug 10, 1989 | Substantially Equivalent |
| K881207 | RES-Q 1, 2, 3, 4 AND 5 | Aug 15, 1988 | Substantially Equivalent |
| K863756 | MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT | Nov 13, 1986 | Substantially Equivalent |
| K850600 | CO-AX VENTILATOR CIRCUIT | May 2, 1985 | Substantially Equivalent |
| K842794 | MAXI-MISER HUMIDIFIER INSERT 1020 & 1021 | Oct 4, 1984 | Substantially Equivalent |
| K842795 | MAXI-MISER HUMIDIFIER INSERT 1030 | Oct 4, 1984 | Substantially Equivalent |
| K841571 | MAXI-MISER WATER TRANSFER SET 1021/1022 | May 30, 1984 | Substantially Equivalent |
| K841569 | MAXI-MISER HUMIDIFIER INSERT 1020 | May 30, 1984 | Substantially Equivalent |