FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
ADHESIVE E.T. TAPE
K Number: K925386
·
Decision Apr 19, 1993
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
23
Review Days
175
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Basic Information
- Device Name
- ADHESIVE E.T. TAPE
- K Number
- K925386
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- B&B Medical Technologies, Inc.
- Date Received
- October 26, 1992
- Decision Date
- April 19, 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 B&B Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030396 | OMNI~NEB; OMNI~MAX | May 7, 2004 | Substantially Equivalent |
| K980407 | HOPE NEBULIZER | May 27, 1998 | Substantially Equivalent |
| K960663 | UNIVERSAL BITE BLOCK | May 17, 1996 | Substantially Equivalent |
| K945816 | QUICK-LOCK | Jan 13, 1995 | Substantially Equivalent |
| K944324 | SURE-LOCK VENTILATOR TUBING HOLDER | Nov 4, 1994 | Substantially Equivalent |
| K935171 | STABILTRACH | Dec 2, 1993 | Substantially Equivalent |
| K923690 | MINI HEART | Oct 20, 1992 | Substantially Equivalent |
| K913015 | HEART NEBULIZER FLOWMETER ADAPTOR | Nov 20, 1991 | Substantially Equivalent |
| K913753 | BODAI NEO2 -SAFE AIRWAY PRESSURE CAP | Oct 23, 1991 | Substantially Equivalent |
| K913000 | HEART NEBULIZER POLE CLAMP | Aug 2, 1991 | Substantially Equivalent |