FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
K Number: K901983
·
Decision Aug 14, 1990
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
14
Review Days
104
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Basic Information
- Device Name
- OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
- K Number
- K901983
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Fittings, Inc.
- Date Received
- May 2, 1990
- Decision Date
- August 14, 1990
- Product Code
- BYX
- 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
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Other Clearances by Medical Fittings, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931043 | MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS | Jun 1, 1993 | Substantially Equivalent |
| K931033 | MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS | Jun 1, 1993 | Substantially Equivalent |
| K920360 | TIMOX OXYGEN TIMER | Aug 3, 1992 | Substantially Equivalent |
| K914980 | HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES | Jan 21, 1992 | Substantially Equivalent |
| K912763 | OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) | Oct 15, 1991 | Substantially Equivalent |
| K905091 | VARIOUS MALE QUICK CONNECTS. | Mar 4, 1991 | Substantially Equivalent |
| K905094 | SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN | Nov 20, 1990 | Substantially Equivalent |
| K904702 | MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS | Oct 31, 1990 | Substantially Equivalent |
| K904701 | MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN | Oct 31, 1990 | Substantially Equivalent |
| K904757 | OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS | Oct 31, 1990 | Substantially Equivalent |