FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
K Number: K920900
·
Decision Mar 18, 1992
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
20
Review Days
21
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Basic Information
- Device Name
- POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
- K Number
- K920900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Polamedco, Inc.
- Date Received
- February 26, 1992
- Decision Date
- March 18, 1992
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K950713 | AIRGUIDE STYLETTE | May 17, 1995 | Substantially Equivalent |
| K933596 | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | Feb 13, 1995 | Substantially Equivalent |
| K950380 | FLEXTITIP STYLETTE | Feb 10, 1995 | Substantially Equivalent |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Apr 19, 1990 | Substantially Equivalent |
| K900457 | CUFFED LINDER NASOTRACHEAL AIRWAY | Apr 16, 1990 | Substantially Equivalent |
| K894516 | VISOSHIELD(TM), SURGICAL EYE PROTECTOR | Sep 12, 1989 | Substantially Equivalent |
| K881496 | LINDER NASOTRACHEAL AIRWAY | May 31, 1988 | Substantially Equivalent |