FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SMARTSIGNS MINPULSE
K Number: K081572
·
Decision Oct 1, 2008
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
8
Review Days
119
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
- SMARTSIGNS MINPULSE
- K Number
- K081572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huntleigh Healthcare , Ltd.
- Date Received
- June 4, 2008
- Decision Date
- October 1, 2008
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP61)
FDA 510(k)
FDA Class 2
·Cardiovascular
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Huntleigh Healthcare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250777 | Sonicaid Team3 | Sep 19, 2025 | Substantially Equivalent |
| K241368 | Sonicaid Team3 | Feb 3, 2025 | Substantially Equivalent |
| K211200 | WoundExpress | Sep 3, 2021 | Substantially Equivalent |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | Sep 6, 2019 | Substantially Equivalent |
| K152228 | Hydroven 12, Hydroven 12 Garments | Apr 4, 2016 | Substantially Equivalent |
| K090285 | SONICAID FM820 AND FM830 ENCORE | Jul 15, 2009 | Substantially Equivalent |
| K060230 | DOPPLEX CENTRALE | Mar 23, 2006 | Substantially Equivalent |