FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLAKE MEDICAL BREATHING TUBE SUPPORT
K Number: K902604
·
Decision Oct 2, 1990
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
2
Review Days
112
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BLAKE MEDICAL BREATHING TUBE SUPPORT
- K Number
- K902604
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Blake Medical, Inc.
- Date Received
- June 12, 1990
- Decision Date
- October 2, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBH), ordered by most recent decision date.
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
DALE ENDOTRACHEAL TUBE HOLDER 270/280
FDA 510(k)
FDA Class 1
·Anesthesiology
HCI TUBE STABILIZER
FDA 510(k)
FDA Class 1
·Anesthesiology
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
FDA 510(k)
FDA Class 1
·Anesthesiology
TRACHE-TITE
FDA 510(k)
FDA Class 1
·Anesthesiology
FLEX BLUE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Blake Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933420 | BREATHING TUBE SUPPORT | Oct 13, 1993 | Substantially Equivalent |