FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K Number: K032803
·
Decision Mar 10, 2004
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
40
Review Days
183
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
- DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
- K Number
- K032803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Datex-Ohmeda
- Date Received
- September 9, 2003
- Decision Date
- March 10, 2004
- Product Code
- BSZ
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSZ), ordered by most recent decision date.
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
FDA 510(k)
FDA Class 2
·Anesthesiology
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
FDA 510(k)
FDA Class 2
·Anesthesiology
Atlan
FDA 510(k)
FDA Class 2
·Anesthesiology
Carestation 750/750c
FDA 510(k)
FDA Class 2
·Anesthesiology
A8, A9 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Datex-Ohmeda
| K Number | Device Name | ||
|---|---|---|---|
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | Aug 8, 2013 | Substantially Equivalent |
| K122445 | AESPIRE 7900, AESPIRE VIEW | Oct 12, 2012 | Substantially Equivalent |
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 | Sep 9, 2011 | Substantially Equivalent |
| K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM | Jun 6, 2007 | Substantially Equivalent |
| K042891 | DATEX-OHMEDA OXY-AFR SENSOR | Jun 29, 2005 | Substantially Equivalent |
| K043572 | COMPATIBILITY ECG TRUNK CABLES | Feb 22, 2005 | Substantially Equivalent |
| K043551 | DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES | Feb 18, 2005 | Substantially Equivalent |
| K043276 | DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE | Dec 23, 2004 | Substantially Equivalent |
| K042771 | GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 | Oct 15, 2004 | Substantially Equivalent |
| K041772 | DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES | Jul 28, 2004 | Substantially Equivalent |