MEDO BUBBLE BATH MA-80, 400, 600 & 700
FDA 510(k) clearance K844064 · decided 1985-01-23
Clearance details
- K-number
- K844064
- Device name
- MEDO BUBBLE BATH MA-80, 400, 600 & 700
- Applicant
- Medo U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-18
- Decision date
- 1985-01-23
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- ILJ
- Device class
- 2
- Regulation number
- 890.5100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Wood Dale, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medo U.S.A.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PARKER 500 (K110994) | Arjohuntleigh, Inc. | 2011-07-06 |
| IMMERSION HYDROBATH (K082951) | Arjo Hospital Equipment AB | 2009-04-08 |
| MBATH 1000 (60) (K052479) | Enneking Medical, Inc. | 2006-01-26 |
| PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (K040772) | Penner Manufacturing, Inc. | 2004-04-05 |
| SUPERIOR BATH, MODEL 6300 (K012061) | Penner Manufacturing, Inc. | 2001-07-19 |
| CASCADE BATH, MODEL 6900 (K012057) | Penner Manufacturing, Inc. | 2001-07-19 |
| RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (K001079) | Arjo, Inc. | 2000-05-01 |
| VANNA BATHING SYSTEM (K993872) | Vancare, Inc. | 2000-02-16 |
| A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (K992779) | Medi-Man Rehabilitation Products, Inc. | 2000-01-13 |
| HYDROTONE-THERMAL CAPSULE SYSTEM (K991184) | Nats Corp. | 1999-06-23 |
| VICHY SHOWER (K980909) | Bouvier Hydro, Inc. | 1998-08-11 |
| EQUINOXE (K980920) | Bouvier Hydro, Inc. | 1998-07-16 |
Recalls involving this device
No recalls on record reference this clearance.