FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
K Number: K860535
·
Decision Apr 1, 1986
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
21
Review Days
48
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
- K Number
- K860535
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Andover Medical, Inc.
- Date Received
- February 12, 1986
- Decision Date
- April 1, 1986
- Product Code
- CAT
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
4 SURE TM NASAL OXYGEN CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
FDA 510(k)
FDA Class 1
·Anesthesiology
CANNULA NASAL OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Andover Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905729 | CANMED 451 | Feb 7, 1991 | Substantially Equivalent |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | Aug 17, 1990 | Substantially Equivalent |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | Jan 12, 1989 | Substantially Equivalent |
| K860636 | FASTRACE III, ECG ELECTRODE | May 9, 1986 | Substantially Equivalent |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | May 8, 1986 | Substantially Equivalent |
| K860283 | AMI CARDIO-PAD | Mar 31, 1986 | Substantially Equivalent |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | Nov 20, 1984 | Substantially Equivalent |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | Nov 20, 1984 | Substantially Equivalent |
| K843411 | THERMAL DILUTION CATHETER | Oct 18, 1984 | Substantially Equivalent |
| K843409 | FLOW-DIRECTED THERMODILUTION CATH | Oct 18, 1984 | Substantially Equivalent |