FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K Number: K191027
·
Decision Mar 18, 2020
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
186
Applicant Total
5
Review Days
335
Basic Information
- Device Name
- Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
- K Number
- K191027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maquet Critical Care AB
- Date Received
- April 18, 2019
- Decision Date
- March 18, 2020
- 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.
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
A5 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
A7 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Maquet Critical Care AB
| K Number | Device Name | ||
|---|---|---|---|
| K230173 | Servo-air Lite Ventilator System | Jul 6, 2023 | Substantially Equivalent |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | Apr 20, 2021 | Substantially Equivalent |
| K182862 | Servo Guard | Oct 21, 2019 | Substantially Equivalent |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Mar 19, 2019 | Substantially Equivalent |