FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALM OPERATING TABLES
K Number: K884019
·
Decision Oct 13, 1988
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
2
Applicant Total
10
Review Days
21
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Basic Information
- Device Name
- ALM OPERATING TABLES
- K Number
- K884019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Alm Surgical Equipment, Inc.
- Date Received
- September 22, 1988
- Decision Date
- October 13, 1988
- Product Code
- FWX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWX | Table, Operating-Room, Mechanical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWX), ordered by most recent decision date.
MOBILE OPHTHALMIC OPERATING TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TABLE, OPERATING, FIELD 6530-00-709-8175
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Alm Surgical Equipment, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982063 | ALM PRISMALIX (PRX) SURGICAL LIGHT | Sep 22, 1998 | Substantially Equivalent |
| K961886 | DRAGER GEMINA WALL-MOUNTED WORKPLACE | Jul 30, 1996 | Substantially Equivalent |
| K961742 | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM | Jul 26, 1996 | Substantially Equivalent |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | Nov 4, 1994 | Substantially Equivalent |
| K942043 | DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E | Jul 13, 1994 | Substantially Equivalent |
| K922409 | ALM ILLUMINATOR SERIES LIGHT SYSTEM | Jan 12, 1993 | Substantially Equivalent |
| K921297 | DRAGER DVE 4000 SERIES SYSTEM | Nov 27, 1992 | Substantially Equivalent |
| K921848 | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | Oct 1, 1992 | Substantially Equivalent |
| K882613 | ALM SURGICAL LAMPS | Jul 18, 1988 | Substantially Equivalent |