FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
2C7125 BLOW BOTTLE
K Number: K780407
·
Decision Apr 10, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
3
Applicant Total
206
Review Days
28
Basic Information
- Device Name
- 2C7125 BLOW BOTTLE
- K Number
- K780407
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5220
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- TRAVENOL LABORATORIES, S.A.
- Date Received
- March 13, 1978
- Decision Date
- April 10, 1978
- Product Code
- BYO
- 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 |
|---|---|---|---|
| BYO | Bottle, Blow | FDA class 1 | Anesthesiology |
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| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | Sep 4, 1987 | Substantially Equivalent |
| K871908 | IV ADMINISTRATION SET | Jul 27, 1987 | Substantially Equivalent |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Apr 17, 1987 | Substantially Equivalent |