FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
K Number: K102363
·
Decision Jan 27, 2011
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
28
Review Days
160
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
- SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
- K Number
- K102363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spsmedical Supply Corp.
- Date Received
- August 20, 2010
- Decision Date
- January 27, 2011
- Product Code
- JOJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOJ), ordered by most recent decision date.
LF Process Indicator Tape for Steam Sterilization
FDA 510(k)
FDA Class 2
·General Hospital
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
FDA 510(k)
FDA Class 2
·General Hospital
DISINTEK PA Test Strips
FDA 510(k)
FDA Class 2
·General Hospital
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
FDA 510(k)
FDA Class 2
·General Hospital
VERIFY STEAM Integrating Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Green Card Bowie-Dick Test (BD115)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Spsmedical Supply Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122024 | SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR | Nov 26, 2013 | Substantially Equivalent |
| K130211 | AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS | Jul 5, 2013 | Substantially Equivalent |
| K111515 | SPSMEDICAL SPORVIEW STEAM BI | Feb 1, 2012 | Substantially Equivalent |
| K110152 | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS | Apr 15, 2011 | Substantially Equivalent |
| K090650 | SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS | Oct 9, 2009 | Substantially Equivalent |
| K081879 | SPSMEDICAL SPORVIEW PA CULTURE SET | Jul 30, 2008 | Substantially Equivalent |
| K070595 | SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR | May 24, 2007 | Substantially Equivalent |
| K063799 | STEAMPLUS STEAM INTEGRATOR | Jan 5, 2007 | Substantially Equivalent |
| K051173 | SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK | May 27, 2005 | Substantially Equivalent |
| K043135 | SPSMEDICAL SPORVIEW PA CULTURE SET | Jan 13, 2005 | Substantially Equivalent |