FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURVEYOR I, RESPIRATORY COMPUTER SYSTEM
K Number: K801526
·
Decision Jul 21, 1980
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
12
Review Days
19
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Basic Information
- Device Name
- SURVEYOR I, RESPIRATORY COMPUTER SYSTEM
- K Number
- K801526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- The Devilbiss Co.
- Date Received
- July 2, 1980
- Decision Date
- July 21, 1980
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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Other Clearances by The Devilbiss Co.
| K Number | Device Name | ||
|---|---|---|---|
| K874041 | DEVILBISS MODEL 8500D | Dec 23, 1987 | Substantially Equivalent |
| K872094 | VACU-AIDE | Oct 15, 1987 | Substantially Equivalent |
| K872826 | ULTRA-NEB 99 ULTRASONIC NEBULIZER | Sep 4, 1987 | Substantially Equivalent |
| K872470 | DEVO/MC44 OXYGEN CONCENTRATOR | Aug 3, 1987 | Substantially Equivalent |
| K854520 | PULMO-AIDE MODEL 5610D | Dec 9, 1985 | Substantially Equivalent |
| K852209 | DEVO/MC29 OXYGEN CONCENTRATOR MC29D | Jun 24, 1985 | Substantially Equivalent |
| K851695 | ULTRA-NEB 100 ULTRASONIC NEBULIZER | Jun 5, 1985 | Substantially Equivalent |
| K830174 | DE VO/44 OXYGEN CONCENTRATOR #444 | Feb 17, 1983 | Substantially Equivalent |
| K792385 | DEVO OXYGEN CONCENTRATOR, MODEL 955 | Dec 5, 1979 | Substantially Equivalent |
| K781073 | PULMO-SONIC | Sep 27, 1978 | Substantially Equivalent |