FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PUL-TRON 100K PROFESSIONAL SPIROMETER
K Number: K891672
·
Decision Jun 16, 1989
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
10
Review Days
87
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Basic Information
- Device Name
- PUL-TRON 100K PROFESSIONAL SPIROMETER
- K Number
- K891672
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Medical Systems, Inc.
- Date Received
- March 21, 1989
- Decision Date
- June 16, 1989
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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Other Clearances by Advanced Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955931 | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) | Aug 14, 1996 | Substantially Equivalent |
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | Jul 18, 1995 | Substantially Equivalent |
| K940898 | MODEL IM77 INTRAPARTUM FETAL MONITOR | Mar 1, 1995 | Substantially Equivalent |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | Jul 22, 1994 | Substantially Equivalent |
| K932278 | PFM PROFESSIONAL 7000 SPIROMETER | Dec 17, 1993 | Substantially Equivalent |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | Jul 11, 1991 | Substantially Equivalent |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Oct 22, 1990 | Substantially Equivalent |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | Jan 9, 1990 | Substantially Equivalent |
| K880756 | MODEL PM-20A PHYSIOLOGICAL MONITOR | Sep 27, 1988 | Substantially Equivalent |