FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINYSTAG MN-1
K Number: K780338
·
Decision Mar 15, 1978
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
52
Review Days
14
Basic Information
- Device Name
- MINYSTAG MN-1
- K Number
- K780338
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- LKB INSTRUMENTS, INC.
- Date Received
- March 1, 1978
- Decision Date
- March 15, 1978
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSF), ordered by most recent decision date.
EDENTEC DIGITAL CHARTER MODEL 3710
FDA 510(k)
FDA Class 1
·Cardiovascular
DASH IV
FDA 510(k)
FDA Class 1
·Cardiovascular
MODEL 556 MONITOR
FDA 510(k)
FDA Class 1
·Cardiovascular
GRI LASERGRAPH(TM) ECG PAPER
FDA 510(k)
FDA Class 1
·Cardiovascular
COLORADO COLOR IMAGING RECORDER
FDA 510(k)
FDA Class 1
·Cardiovascular
GABRIEL MEDICAL CLS THERMAL RECORDER
FDA 510(k)
FDA Class 1
·Cardiovascular
Other Clearances by LKB INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Nov 4, 1987 | Substantially Equivalent |
| K872955 | DELFIA(TM) FERRITIN KIT | Aug 21, 1987 | Substantially Equivalent |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | Jun 17, 1987 | Substantially Equivalent |
| K871599 | DELFIA(TM) HIGE KIT | Jun 12, 1987 | Substantially Equivalent |
| K871644 | DELFIA (TM) HTSH KIT | May 12, 1987 | Substantially Equivalent |
| K864452 | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT | Feb 2, 1987 | Substantially Equivalent |
| K864733 | LKB 2260 MACROTOME | Jan 5, 1987 | Substantially Equivalent |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Dec 18, 1986 | Substantially Equivalent |
| K863422 | DELFIA(TM) CORTISOL KIT | Sep 26, 1986 | Substantially Equivalent |
| K862044 | DELFIA (TM) HCG KIT | Jul 11, 1986 | Substantially Equivalent |