FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSAL LITER BREATHING BAG
K Number: K800155
·
Decision Feb 21, 1980
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
21
Review Days
29
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Basic Information
- Device Name
- DISPOSAL LITER BREATHING BAG
- K Number
- K800155
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dryden Corp.
- Date Received
- January 23, 1980
- Decision Date
- February 21, 1980
- Product Code
- BTC
- 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 |
|---|---|---|---|
| BTC | Bag, Reservoir | FDA class 1 | Anesthesiology |
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Other Clearances by Dryden Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K880923 | PATIENT VENTILATOR ISOLATOR | Sep 6, 1988 | Substantially Equivalent |
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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 |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Mar 21, 1985 | Substantially Equivalent |