FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT VENTILATOR ISOLATOR
K Number: K880923
·
Decision Sep 6, 1988
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
21
Review Days
186
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Basic Information
- Device Name
- PATIENT VENTILATOR ISOLATOR
- K Number
- K880923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dryden Corp.
- Date Received
- March 4, 1988
- Decision Date
- September 6, 1988
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Dryden Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880769 | BREATHING CIRCUIT W/HEATED WIRE | Aug 24, 1988 | Substantially Equivalent |
| 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 |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Mar 21, 1985 | Substantially Equivalent |
| K842843 | DRYDEN SCAVENGER INTERFACE SYSTEM | Jul 27, 1984 | Substantially Equivalent |