FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K Number: K961972
·
Decision Apr 18, 1997
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
24
Review Days
333
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
- MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
- K Number
- K961972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Aequitron Medical, Inc.
- Date Received
- May 20, 1996
- Decision Date
- April 18, 1997
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZQ), ordered by most recent decision date.
Respiration Rate algorithm
FDA 510(k)
FDA Class 2
·Anesthesiology
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
FDA 510(k)
FDA Class 2
·Anesthesiology
Respiree Cardio- Respiratory Monitor System
FDA 510(k)
FDA Class 2
·Anesthesiology
RTMsense Respiratory Monitoring System
FDA 510(k)
FDA Class 2
·Anesthesiology
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
FDA 510(k)
FDA Class 2
·Anesthesiology
Philips VSC-MEDlib
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Aequitron Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952880 | MODEL LP-1000 VOLUME VENTILATOR | Jun 20, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Nov 8, 1994 | Substantially Equivalent |
| K914424 | MODEL 6213 REMOTE ALARM | Sep 10, 1992 | Substantially Equivalent |
| K915381 | PORTABLE OXYGEN GENERATOR | Mar 11, 1992 | Substantially Equivalent |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Sep 19, 1991 | Substantially Equivalent |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Apr 10, 1991 | Substantially Equivalent |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | Nov 30, 1990 | Substantially Equivalent |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | Nov 30, 1990 | Substantially Equivalent |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | Jul 13, 1990 | Substantially Equivalent |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | Jul 13, 1990 | Substantially Equivalent |