FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYMMAN
K Number: K920099
·
Decision Mar 9, 1992
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
13
Review Days
60
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Basic Information
- Device Name
- GYMMAN
- K Number
- K920099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lumiscope Co., Inc.
- Date Received
- January 9, 1992
- Decision Date
- March 9, 1992
- 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 |
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Other Clearances by Lumiscope Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032714 | CARDICARE MODEL MT-301F & MT-301C | Oct 22, 2003 | Substantially Equivalent |
| K954792 | LUMISCOPE MODEL 2018 THERMOMETER | Jun 21, 1996 | Substantially Equivalent |
| K931768 | INTERFERENTIAL CURRENT THERAPY UNIT | Feb 23, 1994 | Substantially Equivalent |
| K925054 | INFRARED LAMP | Jun 29, 1993 | Substantially Equivalent |
| K924081 | LUMISONIC | Nov 9, 1992 | Substantially Equivalent |
| K901849 | LUMISCOPE EMS 8000 | Aug 24, 1990 | Substantially Equivalent |
| K901096 | LUMISCOPE ALTERNATING PRESSURE PAD & PUMP | Aug 21, 1990 | Substantially Equivalent |
| K901726 | LUMISCOPE MICRO 100 | Aug 14, 1990 | Substantially Equivalent |
| K901809 | LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 | Jun 18, 1990 | Substantially Equivalent |
| K894127 | LUMISCOPE MODEL 1000/APCC MODEL 1000 | Sep 6, 1989 | Substantially Equivalent |