FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREAS PV 100 CPAP SYSTEM
K Number: K001553
·
Decision Aug 3, 2000
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
75
Review Days
77
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BREAS PV 100 CPAP SYSTEM
- K Number
- K001553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vital Signs, Inc.
- Date Received
- May 18, 2000
- Decision Date
- August 3, 2000
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZD), ordered by most recent decision date.
Orion
FDA 510(k)
FDA Class 2
·Anesthesiology
ResScan Essentials
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
FDA 510(k)
FDA Class 2
·Anesthesiology
MySleepDash
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Vital Signs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112902 | ENFLOW IV FLUID WARMER | Mar 14, 2012 | Substantially Equivalent |
| K041309 | IMASK TM | Jun 30, 2004 | Substantially Equivalent |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | Oct 15, 2003 | Substantially Equivalent |
| K022402 | DISPOSABLE PRESSURE MANOMETER | Aug 22, 2002 | Substantially Equivalent |
| K021315 | SURE-LOK | Aug 21, 2002 | Substantially Equivalent |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | Mar 7, 2001 | Substantially Equivalent |
| K000441 | BODYGUARD | Apr 11, 2000 | Substantially Equivalent |
| K994044 | CLEEN-ABLE | Feb 25, 2000 | Substantially Equivalent |
| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |
| K984468 | VITAL PEP | Jun 1, 1999 | Substantially Equivalent |