FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARIES
K Number: K873170
·
Decision Sep 25, 1987
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
20
Review Days
45
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
- ARIES
- K Number
- K873170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mountain Medical Equipment, Inc.
- Date Received
- August 11, 1987
- Decision Date
- September 25, 1987
- Product Code
- BYE
- 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 |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYE), ordered by most recent decision date.
Besmed PEEP Valve
FDA 510(k)
FDA Class 2
·Anesthesiology
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
FDA 510(k)
FDA Class 2
·Anesthesiology
B&B BUBBLER
FDA 510(k)
FDA Class 2
·Anesthesiology
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
O_TWO CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WATERPAP VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Mountain Medical Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | Jun 21, 1995 | Substantially Equivalent |
| K923650 | SCOTTY | Jan 15, 1993 | Substantially Equivalent |
| K924684 | MICROFLOW | Dec 15, 1992 | Substantially Equivalent |
| K914916 | ALPINE V | Sep 23, 1992 | Substantially Equivalent |
| K902890 | ASPEN 3 OXYGEN CONCENTRATOR | Jul 19, 1990 | Substantially Equivalent |
| K893531 | CUFF SPECULUM | Jun 22, 1989 | Substantially Equivalent |
| K884084 | PORTABLE OXYGEN GENERATOR | Nov 21, 1988 | Substantially Equivalent |
| K881802 | ALPINE PORTABLE OXYGEN GENERATOR | Jul 8, 1988 | Substantially Equivalent |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | Oct 20, 1987 | Substantially Equivalent |
| K864005 | ALPINE | Jan 28, 1987 | Substantially Equivalent |