FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RES-Q 1, 2, 3, 4 AND 5
K Number: K881207
·
Decision Aug 15, 1988
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
207
Applicant Total
12
Review Days
147
Basic Information
- Device Name
- RES-Q 1, 2, 3, 4 AND 5
- K Number
- K881207
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- NOVA-VENTRX
- Date Received
- March 21, 1988
- Decision Date
- August 15, 1988
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 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 |
| K870382 | DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011 | Mar 6, 1987 | 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 |
| K841569 | MAXI-MISER HUMIDIFIER INSERT 1020 | May 30, 1984 | Substantially Equivalent |
| K841571 | MAXI-MISER WATER TRANSFER SET 1021/1022 | May 30, 1984 | Substantially Equivalent |