Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “BIS ENGINE”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
Filters
Registry
EUDAMED
FDA 510(k)
3
FDA PMA
GUDID
Country / market
United States
3
Risk class
Class I
Class IIa
Class IIb
Class III
Class II (US)
3
More classes (11)
Class A
Class B
Class C
Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
Not classified (FDA)
Verified
Verified only
Category (EMDN)
Browse by category
Apply filters
3 devices found
·
sorted by relevance
Key
Clear all
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
Bis Engine
Aspect Medical Systems, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K011834
Active
Cleared 10 Jul 2001
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Eeg Mis Monitor Model # A-2000; Bis Engine
Aspect Medical Systems, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K011534
Active
Cleared 15 Jun 2001
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Previous
Next
Showing 1-3 of 3