Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
1 active
Filters
1 active
Registry
EUDAMED
FDA 510(k) incl. De Novo
11
FDA PMA
GUDID
11
Country / market
United States
22
Risk class
Class I
6
Class IIa
Class IIb
Class III
Class II (US)
16
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
Reset
22 devices found
·
sorted by relevance
Key
Manufacturer: Spirometrics, Inc.
×
Clear all
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
Spirometrics 2453 & Smi Iii
Spirometrics, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K850045
Active
Cleared 14 Feb 1985
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Spirometrics Breon 2400 & Smi 2400
Spirometrics, Inc.
·
,
United States
(FDA applicant)
FDA 510(k)
K831497
Active
Cleared 24 Jun 1983
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Previous
Next
Showing 21-22 of 22