FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDI-COMP NEONATAL OXYGEN HOOD
K Number: K851666
·
Decision Aug 6, 1985
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
23
Review Days
105
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
- MEDI-COMP NEONATAL OXYGEN HOOD
- K Number
- K851666
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medicomp, Inc.
- Date Received
- April 23, 1985
- Decision Date
- August 6, 1985
- Product Code
- BYL
- 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 |
|---|---|---|---|
| BYL | Tent, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYL), ordered by most recent decision date.
NASCOR IGLOO
FDA 510(k)
FDA Class 1
·Anesthesiology
NASCOR OXYDOME
FDA 510(k)
FDA Class 1
·Anesthesiology
SPAG PAK
FDA 510(k)
FDA Class 1
·Anesthesiology
DIRD INGANT O2 (BIO 2 HOOD)
FDA 510(k)
FDA Class 1
·Anesthesiology
NOVA OXYGEN TENT
FDA 510(k)
FDA Class 1
·Anesthesiology
KEYSTONE OXYGEN TENT
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Medicomp, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K173170 | Epicardia Anywhere | Jan 10, 2018 | Substantially Equivalent |
| K161916 | TelePatch Cardiac Monitor | Dec 21, 2016 | Substantially Equivalent |
| K091696 | SAVI WIRELESS, MODEL PM500 | Oct 26, 2009 | Substantially Equivalent |
| K090834 | EPICARDIA 5000 | May 15, 2009 | Substantially Equivalent |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Mar 24, 2005 | Substantially Equivalent |
| K981119 | CARDIOPAL MODEL NUMBER PM20 | Oct 14, 1998 | Substantially Equivalent |
| K952846 | EPICARDIA | Sep 18, 1995 | Substantially Equivalent |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | Oct 14, 1994 | Substantially Equivalent |
| K900207 | EPICARDIA 4000 | Jul 31, 1990 | Substantially Equivalent |
| K883103 | EPICARDIA PC/FC | Sep 22, 1988 | Substantially Equivalent |