FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STOM-VENT
K Number: K872153
·
Decision Aug 3, 1987
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
72
Applicant Total
6
Review Days
60
Basic Information
- Device Name
- STOM-VENT
- K Number
- K872153
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- GIBECK RESPIRATION
- Date Received
- June 4, 1987
- Decision Date
- August 3, 1987
- Product Code
- BYD
- 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
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Other Clearances by GIBECK RESPIRATION
| K Number | Device Name | ||
|---|---|---|---|
| K881657 | HUMID-VENT FILTER | Jun 24, 1988 | Substantially Equivalent |
| K881656 | HUMID-VENT 2 S FLEX | Jun 16, 1988 | Substantially Equivalent |
| K881644 | HUMID-VENT 2 S | Jun 10, 1988 | Substantially Equivalent |
| K873768 | HUMID-VENT(R) 2 PORT | Nov 24, 1987 | Substantially Equivalent |
| K873767 | HUMID-VENT(R) MINI | Nov 6, 1987 | Substantially Equivalent |