FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CSS-60 DIGITAL HEART RATE METER
K Number: K780702
·
Decision May 19, 1978
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
38
Review Days
24
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
- CSS-60 DIGITAL HEART RATE METER
- K Number
- K780702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Burdick Corp.
- Date Received
- April 25, 1978
- Decision Date
- May 19, 1978
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (Model 2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Burdick Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K942565 | ALTAIR-DISC RECORDER | Dec 5, 1994 | Substantially Equivalent |
| K941351 | BURDICK PRO2 OXIMETER | Oct 13, 1994 | Substantially Equivalent |
| K904032 | ELITE II ELECTROCARDIOGRAPH | Jul 24, 1991 | Substantially Equivalent |
| K903565 | E560 ELECTROCARDIOGRAPH | Jul 24, 1991 | Substantially Equivalent |
| K900729 | NEOSERV 824 | Jun 8, 1990 | Substantially Equivalent |
| K885085 | ERGOMED 840/ERGOMED 840L | Oct 3, 1989 | Substantially Equivalent |
| K892835 | E350 ELECTROCARDIOGRAPH | Jun 1, 1989 | Substantially Equivalent |
| K883440 | E550 ELECTROCARDIOGRAPH | Jan 17, 1989 | Substantially Equivalent |
| K873774 | M300 MONITOR/CONTROLLER T500 TREADMILL | Nov 6, 1987 | Substantially Equivalent |
| K870920 | ELITE ELECTROCARDIOGRAPH | Apr 13, 1987 | Substantially Equivalent |