FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AEROSOL EFFUSION SYSTEM #1740
K Number: K770771
·
Decision Jun 2, 1977
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
21
Applicant Total
33
Review Days
35
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Basic Information
- Device Name
- AEROSOL EFFUSION SYSTEM #1740
- K Number
- K770771
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5995
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Date Received
- April 28, 1977
- Decision Date
- June 2, 1977
- Product Code
- BYH
- 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 |
|---|---|---|---|
| BYH | Drain, Tee (Water Trap) | FDA class 1 | Anesthesiology |
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Other Clearances by Hudson Oxygen Therapy Sales Co.
| K Number | Device Name | ||
|---|---|---|---|
| K902062 | PEEP VALVE | Sep 4, 1990 | Substantially Equivalent |
| K900783 | MDI ADAPTOR | Jul 18, 1990 | Substantially Equivalent |
| K900470 | IN-THE NEBULIZER | May 18, 1990 | Substantially Equivalent |
| K895589 | MANUAL RESUSCITATOR | Mar 30, 1990 | Substantially Equivalent |
| K896136 | INFANT C.P.A.P. MONITOR | Jan 9, 1990 | Substantially Equivalent |
| K895231 | CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER | Oct 27, 1989 | Substantially Equivalent |
| K895747 | VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR | Oct 27, 1989 | Substantially Equivalent |
| K890035 | BACTERIA FILTER | May 5, 1989 | Substantially Equivalent |
| K870895 | NO. 1552, VALVED VENTI-COMP | May 4, 1987 | Substantially Equivalent |
| K871157 | C.P.A.P. NASAL CANNULA | Apr 21, 1987 | Substantially Equivalent |