FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
E.T. TAPE II
K Number: K902065
·
Decision Jul 23, 1990
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
23
Review Days
76
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Basic Information
- Device Name
- E.T. TAPE II
- K Number
- K902065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- B&B Medical Technologies, Inc.
- Date Received
- May 8, 1990
- Decision Date
- July 23, 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 |
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|---|---|---|---|
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| 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 |
| K925386 | ADHESIVE E.T. TAPE | Apr 19, 1993 | Unknown |
| 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 |