FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATHING CIRCUIT W/HEATED WIRE
K Number: K880769
·
Decision Aug 24, 1988
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
21
Review Days
177
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Basic Information
- Device Name
- BREATHING CIRCUIT W/HEATED WIRE
- K Number
- K880769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5270
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dryden Corp.
- Date Received
- February 29, 1988
- Decision Date
- August 24, 1988
- Product Code
- BZE
- 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 |
|---|---|---|---|
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZE), ordered by most recent decision date.
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
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Other Clearances by Dryden Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880923 | PATIENT VENTILATOR ISOLATOR | Sep 6, 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 |