FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREATHING TUBE SUPPORT
K Number: K933420
·
Decision Oct 13, 1993
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
2
Review Days
92
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Basic Information
- Device Name
- BREATHING TUBE SUPPORT
- K Number
- K933420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Blake Medical, Inc.
- Date Received
- July 13, 1993
- Decision Date
- October 13, 1993
- Product Code
- CBH
- 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 |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | FDA class 1 | Anesthesiology |
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Other Clearances by Blake Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902604 | BLAKE MEDICAL BREATHING TUBE SUPPORT | Oct 2, 1990 | Substantially Equivalent |