FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRODUCER FOR ENDOTRACHEAL TUBE
K Number: K820451
·
Decision Mar 26, 1982
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
5
Applicant Total
43
Review Days
36
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Basic Information
- Device Name
- INTRODUCER FOR ENDOTRACHEAL TUBE
- K Number
- K820451
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5780
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Imed Corp.
- Date Received
- February 18, 1982
- Decision Date
- March 26, 1982
- Product Code
- BWB
- 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 |
|---|---|---|---|
| BWB | Forceps, Tube Introduction | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K951922 | ADMINISTRATION SETS WITH BALL FLOAT | Jul 19, 1995 | Substantially Equivalent |
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS | Jun 21, 1995 | Substantially Equivalent |
| K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | Feb 14, 1995 | Substantially Equivalent |
| K945070 | VERSASAE PLASTIC CANNULA- 11 GAUGE | Jan 13, 1995 | Substantially Equivalent |
| K931173 | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH | Apr 15, 1994 | Substantially Equivalent |
| K933144 | GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER | Oct 12, 1993 | Substantially Equivalent |
| K924718 | SHROUDED NEEDLE DEVICES | Jun 18, 1993 | Substantially Equivalent |