FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
K Number: K893760
·
Decision Aug 10, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
12
Review Days
83
Basic Information
- Device Name
- CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
- K Number
- K893760
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- NOVA-VENTRX
- Date Received
- May 19, 1989
- Decision Date
- August 10, 1989
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | 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 |
| K881207 | RES-Q 1, 2, 3, 4 AND 5 | Aug 15, 1988 | 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 |