FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
K Number: K983572
·
Decision Mar 19, 1999
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
9
Review Days
157
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Basic Information
- Device Name
- SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
- K Number
- K983572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healthdyne Technologies, Inc.
- Date Received
- October 13, 1998
- Decision Date
- March 19, 1999
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Healthdyne Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974453 | NASAL INTERFACE MODEL 7910 | Aug 4, 1998 | Substantially Equivalent |
| K974879 | MODEL 7410 VOYAGER | Jun 29, 1998 | Substantially Equivalent |
| K972614 | TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 | Jan 20, 1998 | Substantially Equivalent |
| K971867 | ALICE 4R SYSTEM | Aug 13, 1997 | Substantially Equivalent |
| K971545 | PROTEGE LIQUID OXYGEN SYSTEM | Jul 25, 1997 | Substantially Equivalent |
| K970173 | MODEL 1700 TRANQUILITY BILEVEL SYSTEM | Apr 16, 1997 | Substantially Equivalent |
| K962517 | MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV | Feb 20, 1997 | Substantially Equivalent |
| K943509 | 7300 NASAL CPAP SYSTEM | Aug 5, 1994 | Substantially Equivalent |