FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO KION ANESTHESIA SYSTEM
K Number: K001315
·
Decision May 26, 2000
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
187
Applicant Total
63
Review Days
30
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
- MODIFICATION TO KION ANESTHESIA SYSTEM
- K Number
- K001315
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Elema AB
- Date Received
- April 26, 2000
- Decision Date
- May 26, 2000
- 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 Siemens Elema AB
| K Number | Device Name | ||
|---|---|---|---|
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Sep 5, 2003 | Substantially Equivalent |
| K010923 | KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E | Jan 23, 2002 | Substantially Equivalent |
| K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E | Dec 18, 2001 | Substantially Equivalent |
| K002137 | CATHCOR DESKTOP | Oct 5, 2000 | Substantially Equivalent |
| K970839 | SERVO VENTILATOR 300A | Oct 14, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 | Oct 25, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K872278 | SIEMENS O2-AIR MIXER 965 | Sep 3, 1987 | Substantially Equivalent |
| K871354 | SERVO VENTILATOR 900 C/D | Jul 21, 1987 | Substantially Equivalent |
| K871829 | SIEMENS DRY AIR COMPRESSOR | Jun 15, 1987 | Substantially Equivalent |