FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASOPHARYNGEAL AIRWAY-ROBERTAZZI
K Number: K850644
·
Decision Mar 21, 1985
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
18
Applicant Total
21
Review Days
30
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Basic Information
- Device Name
- NASOPHARYNGEAL AIRWAY-ROBERTAZZI
- K Number
- K850644
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dryden Corp.
- Date Received
- February 19, 1985
- Decision Date
- March 21, 1985
- Product Code
- BTQ
- 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 |
|---|---|---|---|
| BTQ | Airway, Nasopharyngeal | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTQ), ordered by most recent decision date.
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CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY
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Other Clearances by Dryden Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K882285 | NONREBREATHING CIRCUIT | Aug 16, 1988 | Substantially Equivalent |
| K873928 | UNIVERSAL TOURNIQUET | Oct 23, 1987 | Substantially Equivalent |
| K873927 | REUSEABLE BREATHING TUBES | Oct 20, 1987 | Substantially Equivalent |
| K870859 | BAG-TAIL BLEED VALVE | Aug 3, 1987 | Substantially Equivalent |
| K871386 | BREATHING CIRCUIT | May 29, 1987 | Substantially Equivalent |
| K870858 | BADGWELL SAMPLING CATHETER | May 14, 1987 | Substantially Equivalent |
| K861540 | DISPOSABLE BERMAN AND GUEDEL AIRWAYS | May 2, 1986 | Substantially Equivalent |
| K842843 | DRYDEN SCAVENGER INTERFACE SYSTEM | Jul 27, 1984 | Substantially Equivalent |